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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 K040501
Device Name DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX
Applicant
Musculoskeletal Transplant Foundation
125 May St.
Edison,  NJ  08837
Applicant Contact KAREN HARDWICK
Correspondent
Musculoskeletal Transplant Foundation
125 May St.
Edison,  NJ  08837
Correspondent Contact KAREN HARDWICK
Regulation Number872.3930
Classification Product Code
NUN  
Date Received02/26/2004
Decision Date 04/29/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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