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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Animal Source
510(k) Number K112575
Device Name GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO
Applicant
GEISTLICH PHARMA AG
555 TWELFTH STREET, NW
WASHINGTON,  DC  20004 -1206
Applicant Contact DANIEL A KRACOV
Correspondent
GEISTLICH PHARMA AG
555 TWELFTH STREET, NW
WASHINGTON,  DC  20004 -1206
Correspondent Contact DANIEL A KRACOV
Regulation Number872.3930
Classification Product Code
NPM  
Subsequent Product Code
NPL  
Date Received09/06/2011
Decision Date 12/27/2011
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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