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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 K070093
Device Name OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE
Applicant
CEREMED INC.
3643 LENAWEE AVE.
LOS ANGELES,  CA  90016
Applicant Contact TADEUSZ WELLISZ M.D.
Correspondent
CEREMED INC.
3643 LENAWEE AVE.
LOS ANGELES,  CA  90016
Correspondent Contact TADEUSZ WELLISZ M.D.
Regulation Number874.3620
Classification Product Code
KHJ  
Subsequent Product Code
MTJ  
Date Received01/10/2007
Decision Date 01/24/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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