Product Classification | 合法醫療器材資訊網
Note:FDAhasexemptedalmostallclassIdevices(withtheexceptionof...apremarketnotificationapplicationandfdaclearanceisnotrequiredbefore...PleaseseetheDeviceRegistrationandListingwebsite12foradditionalinformation.
References Office of Neurological and Physical Medicine Devices (www.fda.gov) TPLC Product Code Report (www.accessdata.fda.gov) Device dorsal root ganglion stimulator for pain relief Definition Stimulation of the dorsal root ganglion for the treatment of chronic, intractable pain of the lower limbs. Physical State Main components include implanted leads, implanted neurostimulator, and external programmers ...
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Condom effectiveness | 合法醫療器材資訊網
由 DJ Porche 著作 · 1998 · 被引用 12 次 — Since latex condoms are regulated by the US Food and Drug Administration (FDA) as medical devices, FDA regulations govern latex condom manufacturing ... Read More
Establishment Registration & Device Listing | 合法醫療器材資訊網
CHURCH & DWIGHT CO., INC.9, VA/USA. 1122329, 2021. condom - Naturalamb condoms; Trojan ENZ; Trojan Groove Lubricated; ... Read More
FDA Approved Condoms | 合法醫療器材資訊網
Condoms are regarded by the United States Food and Drug Administration (FDA) as “Class II medical devices”, this designation also includes pregnancy tests and ... Read More
FDA Condom Quality Control for Class II Devices ... | 合法醫療器材資訊網
Yes, condom manufacturers perform a bunch of tests but it's the regulatory officials from the U.S. FDA that give condoms their final quality approval before ... Read More
Labeling for Natural Rubber Latex Condoms Classified Under ... | 合法醫療器材資訊網
2008年12月23日 — A special controls guidance for male condoms made from natural rubber ... document list the issues requiring special controls identified by FDA and ... in 21 CFR part 807, subpart E, have been approved under OMB control ... Read More
Latex Condoms for Men Abbrev510KS | 合法醫療器材資訊網
request to [email protected] to receive a copy of the guidance. Please use ... marketed device that does not require premarket approval. Unless ... A list of recognized standards is maintained on the CDRH website and is updated ... Read More
Product Classification | 合法醫療器材資訊網
Note: FDA has exempted almost all class I devices (with the exception of ... a premarket notification application and fda clearance is not required before ... Please see the Device Registration and Listing website12 for additional information. Read More
Testing Guidance for Male Condoms Made From New ... | 合法醫療器材資訊網
2018年3月23日 — This list of questions may not be all inclusive or specific for all non-latex materials. ... FDA recognizes that condoms are used during anal intercourse for ... Type II error ( ); c) expected breakage rate of the approved condom; ... Read More
The 9 Best Condoms of 2021 | 合法醫療器材資訊網
Read reviews and buy the best condoms from top brands including LifeStyles, Trojan, Durex, and ... This option from Kimono is FDA-approved for its strength. Read More
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