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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Malar
510(k) Number K960362
Device Name PERMAMESH HYDROXYLAPATITE MATRIX
Applicant
Ceramed Corp.
12860 W. Cedar Dr.,
Suite 110
Lakewood,  CO  80228
Applicant Contact BARBARA A WATSON
Correspondent
Ceramed Corp.
12860 W. Cedar Dr.,
Suite 110
Lakewood,  CO  80228
Correspondent Contact BARBARA A WATSON
Regulation Number878.3550
Classification Product Code
LZK  
Date Received01/25/1996
Decision Date 03/20/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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