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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Barrier, Animal Source, Intraoral
510(k) Number K010952
Device Name SURGISIS GUIDED TISSUE REGENERATION MATRIX
Applicant
Cook Biotech, Inc.
3055 Kent Ave.
West Lafayette,  IN  47906 -1076
Applicant Contact MARK BLEYER
Correspondent
Cook Biotech, Inc.
3055 Kent Ave.
West Lafayette,  IN  47906 -1076
Correspondent Contact MARK BLEYER
Regulation Number872.3930
Classification Product Code
NPL  
Date Received03/30/2001
Decision Date 06/10/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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