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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
Applicant Contact CHELSEA MITCHELL
Correspondent
CEREMED, INC.
3643 LENAWEE AVE.
LOS ANGELES,  CA  90016
Correspondent Contact CHELSEA MITCHELL
Regulation Number874.3620
Classification Product Code
KHJ  
Date Received08/22/2012
Decision Date 11/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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