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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wax, bone
510(k) Number K041363
FOIA Releasable 510(k) K041363
Device Name AOC BONE WAX
Applicant
CEREMED INC.
3643 LENAWEE AVE.
LOS ANGELES,  CA  90016
Applicant Contact TADEUSZ WEKKUSZ MD
Correspondent
CEREMED INC.
3643 LENAWEE AVE.
LOS ANGELES,  CA  90016
Correspondent Contact TADEUSZ WEKKUSZ MD
Classification Product Code
MTJ  
Date Received05/21/2004
Decision Date 07/27/2004
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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