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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 K010701
Device Name MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER
Applicant
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Pl.
Memphis,  TN  38132
Applicant Contact RIHCARD W TREHARNE
Correspondent
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Pl.
Memphis,  TN  38132
Correspondent Contact RIHCARD W TREHARNE
Regulation Number872.3930
Classification Product Code
LYC  
Date Received03/08/2001
Decision Date 06/05/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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