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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 K071555
Device Name FORTAGEN ORAL MEMBRANE
Applicant
ORGANOGENESIS, INC.
150 DAN RD.
CANTON,  MA  02021
Applicant Contact PATRICK R BILBO
Correspondent
ORGANOGENESIS, INC.
150 DAN RD.
CANTON,  MA  02021
Correspondent Contact PATRICK R BILBO
Regulation Number872.3930
Classification Product Code
NPL  
Date Received06/07/2007
Decision Date 08/30/2007
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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