510(k) Premarket Notification | 合法醫療器材資訊網
systemiiihaloring17,JEROMEMEDICAL,K93015318,08/06/1993.jmscervicaltractiondevice/halodevice19,JEROMEMEDICAL,K88287720,09/30/1988.
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.
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References Learn more... (www.fda.gov)
"JEROME" CERVICAL TRACTION SYSTEM "JEROME" CERVICAL TRACTION SYSTEM “姆樂”醫療用膠布及繃帶 (未滅菌) sealapex root canal sealer composition sealapex vs ah plus sealapex sybronendo TwitchView Boston scientific ent DreamWear Nasal mask 資策會l
"傑若米" 頸胸椎固定架系統"JEROME" CERVICAL TRACTION ... | 合法醫療器材資訊網
"傑若米" 頸胸椎固定架系統"JEROME" CERVICAL TRACTION SYSTEM / 詳如中文仿單核定本/ 藥要看提供簡單的介面檢索國內有註冊登記的藥品資訊. Read More
External fixation system for the neck | 合法醫療器材資訊網
1994年4月12日 — The device comprises an truncated elliptical member (halo) adapted ... 5062415, Cervical traction orthotic device, 1991-11-05, Weatherby et al. Read More
510(k) Premarket Notification | 合法醫療器材資訊網
system iii halo ring17, JEROME MEDICAL, K93015318, 08/06/1993. jms cervical traction device/halo device19, JEROME MEDICAL, K88287720, 09/30/1988. Read More
EP1030613A4 | 合法醫療器材資訊網
US6921376B2 * 2001-10-23 2005-07-26 The Jerome Group, Inc. Cervical brace ... Ohana Medical Concepts, Llc Cervical spine brace and traction device. Read More
WO1999022660A1 | 合法醫療器材資訊網
US6921376B2 * 2001-10-23 2005-07-26 The Jerome Group, Inc. Cervical brace ... Ohana Medical Concepts, Llc Cervical spine brace and traction device. Read More
US4620530A | 合法醫療器材資訊網
The invention pertains to a traction brace for the head and neck wherein a ... New from Jerome Medical Systems Halo Traction Jerome Medical Systems, Inc., ... Read More
EP1945155A2 | 合法醫療器材資訊網
A traction device having an adjustable tensioning mechanism, the traction device attachable to a head support and a cervical collar. The tensioning mechanism includes a ... Application filed by Jerome Group Inc. 2008-07-23. Publication of ... Read More
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【"傑若米" 頸胸椎固定架系統】許可證字號:衛署醫器輸字第013754號
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