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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 K033815
Device Name BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN
Applicant
GEISTLICH-PHARMA
1301 K STREET NW
SUITE 600, EAST TOWER
WASHINGTON,  DC  20005
Applicant Contact PETER S REICHERTZ
Correspondent
GEISTLICH-PHARMA
1301 K STREET NW
SUITE 600, EAST TOWER
WASHINGTON,  DC  20005
Correspondent Contact PETER S REICHERTZ
Regulation Number872.3930
Classification Product Code
NPM  
Date Received12/09/2003
Decision Date 01/15/2004
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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