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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 K091636
Device Name OSTENE CT, AOC CT, OSTEOTENE, CERETENE
Applicant
Ceremed , Inc.
3643 Lenawee Ave.
Los Angeles,  CA  90016
Applicant Contact TADEUSZ WELLISZ
Correspondent
Ceremed , Inc.
3643 Lenawee Ave.
Los Angeles,  CA  90016
Correspondent Contact TADEUSZ WELLISZ
Classification Product Code
MTJ  
Date Received06/04/2009
Decision Date 06/22/2009
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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