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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene
510(k) Number K042038
Device Name MTF ALLOGRAFT ANCHOR
Applicant
Musculoskeletal Transplant Foundation
9109 Copenhaver Dr.
Potomac,  MD  20854
Applicant Contact NORMAN F ESTRIN
Correspondent
Musculoskeletal Transplant Foundation
9109 Copenhaver Dr.
Potomac,  MD  20854
Correspondent Contact NORMAN F ESTRIN
Regulation Number878.5000
Classification Product Code
GAT  
Date Received07/29/2004
Decision Date 12/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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