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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 K122894
FOIA Releasable 510(k) K122894
Device Name GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN, GEISTLICH PERIO SYSTEM COMBI PACK, GEISTLIC
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  
Date Received09/20/2012
Decision Date 02/15/2013
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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