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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name polymer, ent synthetic-polyamide (mesh or foil material)
510(K) Number K122561
Device Name ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN
Applicant
CEREMED, INC.
3643 lenawee ave.
los angeles,  CA  90016
Contact chelsea mitchell
Regulation Number874.3620
Classification Product Code
KHJ  
Date Received08/22/2012
Decision Date 11/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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