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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
Predetermined Change
Control Plan Authorized		 No
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