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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 K042197
Device Name BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION
Applicant
ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE
1301 K STREET NW
SUITE 600
WASHINGTON,  DC  20005
Applicant Contact PETER S REICHERTZ
Correspondent
ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE
1301 K STREET NW
SUITE 600
WASHINGTON,  DC  20005
Correspondent Contact PETER S REICHERTZ
Regulation Number872.3930
Classification Product Code
NPL  
Date Received08/13/2004
Decision Date 11/15/2004
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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