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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical
510(k) Number K050246
Device Name SIS DERMAL AUGMENTATION STRAND
Applicant
Cook Biotech, Inc.
1425 Innovation Place
West Lafayette,  IN  47906 -1000
Applicant Contact MARK BLEYER
Correspondent
Cook Biotech, Inc.
1425 Innovation Place
West Lafayette,  IN  47906 -1000
Correspondent Contact MARK BLEYER
Regulation Number878.3300
Classification Product Code
FTM  
Date Received02/02/2005
Decision Date 05/19/2005
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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