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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
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