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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, ventricular, general & plastic surgery
510(k) Number K862584
Device Name OSTEOTOMY DRAINAGE TUBE
Applicant
TREACE MEDICAL, INC.
SUITE 400
22 NORTH SECOND STREET
MEMPHIS,  TN  38103
Applicant Contact WILLIAM H THOMAS,JR
Correspondent
TREACE MEDICAL, INC.
SUITE 400
22 NORTH SECOND STREET
MEMPHIS,  TN  38103
Correspondent Contact WILLIAM H THOMAS,JR
Regulation Number878.4200
Classification Product Code
GBS  
Date Received07/07/1986
Decision Date 08/12/1986
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
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