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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, synthetic
510(k) Number K071817
Device Name OSTEOGRAF/N-300
Applicant
DENTSPLY INTERNTIONAL
221 W. PHILADELPHIA ST. STE.60
SUSQUEHANNA COMMERCE CRT. WEST
YORK,  PA  17404
Applicant Contact HELEN LEWIS
Correspondent
DENTSPLY INTERNTIONAL
221 W. PHILADELPHIA ST. STE.60
SUSQUEHANNA COMMERCE CRT. WEST
YORK,  PA  17404
Correspondent Contact HELEN LEWIS
Regulation Number872.3930
Classification Product Code
LYC  
Date Received07/03/2007
Decision Date 09/04/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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