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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K844377
Device Name SILICONE
Applicant
Treace Medical, Inc.
Suite 400
22 N. Second St.
Memphis,  TN  38103
Applicant Contact WILLIAM H THOMAS
Correspondent
Treace Medical, Inc.
Suite 400
22 N. Second St.
Memphis,  TN  38103
Correspondent Contact WILLIAM H THOMAS
Date Received11/13/1984
Decision Date 03/18/1985
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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