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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 K010320
Device Name MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM
Applicant
DEPUY ACROMED
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Applicant Contact KAREN F JURCZAK
Correspondent
DEPUY ACROMED
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Correspondent Contact KAREN F JURCZAK
Regulation Number872.3930
Classification Product Code
LYC  
Date Received02/02/2001
Decision Date 03/01/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Special
Reviewed by Third Party No
Combination Product No
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