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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
Original Applicant
GEISTLICH PHARMA AG
555 twelfth street, nw
washington,  DC  20004 -1206
Original 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
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