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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name barrier, synthetic, intraoral
510(k) Number K960724
FOIA Releasable 510(k) K960724
Device Name BIO-GIDE RESORBABLE BILAYER MEMBRANE
Applicant
GEISTLICH-PHARMA
1050 CONNECTICUT AVE. N.W.
WASHINGTON,  DC  20036
Applicant Contact PETER S REICHERTZ
Correspondent
GEISTLICH-PHARMA
1050 CONNECTICUT AVE. N.W.
WASHINGTON,  DC  20036
Correspondent Contact PETER S REICHERTZ
Regulation Number872.3930
Classification Product Code
NPK  
Date Received02/22/1996
Decision Date 06/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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