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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
Predetermined Change
Control Plan Authorized		 No
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