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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, human source
510(k) Number K080462
Device Name PROGENIX DBM PUTTY
Applicant
MEDTRONIC SOFAMOR DANEK
1800 PYRAMID PLACE
MEMPHIS,  TN  38132
Applicant Contact MICHELLE OBENAUER
Correspondent
MEDTRONIC SOFAMOR DANEK
1800 PYRAMID PLACE
MEMPHIS,  TN  38132
Correspondent Contact MICHELLE OBENAUER
Regulation Number872.3930
Classification Product Code
NUN  
Date Received02/20/2008
Decision Date 05/13/2008
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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