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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 K003286
Device Name SYMPHONY GRAFT DELIVERY SYSTEM
Applicant
Depuyacromed
325 Paramount Dr.
Raynham,  MA  02767 -0350
Applicant Contact FRANK MAAS
Correspondent
Depuyacromed
325 Paramount Dr.
Raynham,  MA  02767 -0350
Correspondent Contact FRANK MAAS
Regulation Number872.3930
Classification Product Code
LYC  
Date Received10/20/2000
Decision Date 01/18/2001
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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