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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 K082058
Device Name DYNAMATRIX
Applicant
Cook Biotech, Inc.
11234 El Camino Real
Suite 200
San Diego,  CA  92130
Applicant Contact DAVID J COLLETTE
Correspondent
Cook Biotech, Inc.
11234 El Camino Real
Suite 200
San Diego,  CA  92130
Correspondent Contact DAVID J COLLETTE
Regulation Number872.3930
Classification Product Code
NPL  
Date Received07/21/2008
Decision Date 10/02/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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