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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 K842718
Device Name HYDROXYAPATITE
Applicant
Depuy, Inc.
P.O. Box 988
Warsaw,  IN  46581
Applicant Contact STEPHEN M DOYLE
Correspondent
Depuy, Inc.
P.O. Box 988
Warsaw,  IN  46581
Correspondent Contact STEPHEN M DOYLE
Regulation Number872.3930
Classification Product Code
LYC  
Date Received07/13/1984
Decision Date 11/07/1984
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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