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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Support, Patient Position
510(k) Number K861915
Device Name SURGICAL HEAD SUPPORT
Applicant
TREACE MEDICAL, INC.
SUITE 400
22 NORTH SECOND STREET
MEMPHIS,  TN  38103
Applicant Contact THOMAS JR
Correspondent
TREACE MEDICAL, INC.
SUITE 400
22 NORTH SECOND STREET
MEMPHIS,  TN  38103
Correspondent Contact THOMAS JR
Regulation Number868.6820
Classification Product Code
CCX  
Date Received05/19/1986
Decision Date 05/30/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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