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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 K060987
Device Name OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31
Applicant
Cp Medical
5203 Bristol Industrial Way
Buford,  GA  30518
Applicant Contact BETSY CORTELLONI
Correspondent
Cp Medical
5203 Bristol Industrial Way
Buford,  GA  30518
Correspondent Contact BETSY CORTELLONI
Classification Product Code
MTJ  
Date Received04/10/2006
Decision Date 11/02/2006
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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