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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mallet
510(k) Number K882349
Device Name MALLET, SURGICAL
Applicant
Treace Medical, Inc.
Suite 400
22 N. Second St.
Memphis,  TN  38103
Applicant Contact WILLIAM H THOMAS,JR
Correspondent
Treace Medical, Inc.
Suite 400
22 N. Second St.
Memphis,  TN  38103
Correspondent Contact WILLIAM H THOMAS,JR
Regulation Number878.4800
Classification Product Code
HXL  
Date Received06/07/1988
Decision Date 06/23/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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