510(k) Premarket Notification | 合法醫療器材資訊網
2021年3月18日—DeviceClassificationName,mask,surgical22.510(k)Number,K201624.DeviceName,SpinCareDisposableProtectiveMask.Applicant ...
A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.
Learn more...[1]
References Learn more... (www.fda.gov)
Spincare RECELL Nanomedic RECELL recell video Avita recell recell procedure recell® fda avita recell recell autologous cell harvesting device cpt code for recell temporary filling price “愛德華”菲斯歐二尖瓣膜修補環 "YIH JIANG" Surgical apparel (Non-Sterile) lorell big and tall leather chair with ultracoil comfort 壓縮骨螺絲系統 “凱石”牙科傑耐斯植體 dailies colors parameters 白內障手術 推薦
Evaluation of the SpinCare™ System in the Treatment of ... | 合法醫療器材資訊網
2016年12月20日 — U.S. FDA Resources. Arms and Interventions ... Patients with partial thickness burns treated with the SpinCare dressing. Read More
510(k) Premarket Notification | 合法醫療器材資訊網
2021年3月18日 — Device Classification Name, mask, surgical22. 510(k) Number, K201624. Device Name, Spin Care Disposable Protective Mask. Applicant ... Read More
Second skin | 合法醫療器材資訊網
2019年3月4日 — The product, called SpinCare, can be operated by physicians and other ... adding that while seeking FDA approval, SpinCare has gained the CE ... Read More
Company Profile | 合法醫療器材資訊網
Nanomedic Technologies Ltd. is an Israeli bio-medical therapeutics technology company specializing in research, development, and distribution of its ... Read More
Spincare Wound Care System | 合法醫療器材資訊網
The Spincare matrix serves as a temporary skin layer until the full healing of the wound with no need to replace or change it peels off on its own when the ... Read More
Research | 合法醫療器材資訊網
The Spincare Wound Care System, is the only system that integrates electrospinning technology into a portable, bedside device, offering immediate wound care ... Read More
FDA approves first spray | 合法醫療器材資訊網
2018年9月21日 — A kit that sprays on skin cells to treat burns just won approval from the FDA. Its supporters say it will transform how burns are treated. Read More
March 2021 510(K) Clearances | 合法醫療器材資訊網
2021年4月6日 — ... 79211 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Spin Care Disposable Protective Mask SpinTech LLC 510(k) NO: K201624(Traditional) ATTN: ... Read More
Revolutionary spray | 合法醫療器材資訊網
The Spincare device sprays a nanofiber coating on any wound to protect and ... half of this year after receiving FDA clearance,” says Barak. Read More
Citrine Global Corp. (OTCQB | 合法醫療器材資訊網
2020年6月16日 — Nanomedic developed SpinCare™, the first and only system that integrates the revolutionary electrospinning technology into a portable, ... Read More
相關資訊整理
【培得 彈性膠布 (未滅菌)】許可證字號:衛署醫器輸壹字第005173號
器材品名:培得彈性膠布(未滅菌)許可證字號:衛署醫器輸壹字第005173號註銷狀態:已註銷註銷日期:2012/11/05註銷理由:許可證已...
【屈臣氏6片裝水泡膠片】許可證字號:衛署醫器輸壹字第004064號
器材品名:屈臣氏6片裝水泡膠片許可證字號:衛署醫器輸壹字第004064號註銷狀態:已註銷註銷日期:2013/01/21註銷理由:有效日期:2...
【恩莎繃帶(未滅菌)】許可證字號:衛署醫器輸壹字第001584號
器材品名:恩莎繃帶(未滅菌)許可證字號:衛署醫器輸壹字第001584號註銷狀態:已註銷註銷日期:2012/11/19註銷理由:許可證已逾有...
【“愛膚妥”理傷自體細胞採集處理裝置】許可證字號:衛署醫器輸字第019003號
器材品名:“愛膚妥”理傷自體細胞採集處理裝置許可證字號:衛署醫器輸字第019003號註銷狀態:已註銷註銷日期:2019/12/13註銷理由...