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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Traction, Non-Powered
510(k) Number K855179
Device Name TRANSFER-TRAX (TM) SPLINT TRACTION
Applicant
Comfortex, Inc.
420 Main St.
Winona,  MN  55987
Applicant Contact DONALD SALYARDS
Correspondent
Comfortex, Inc.
420 Main St.
Winona,  MN  55987
Correspondent Contact DONALD SALYARDS
Regulation Number888.5850
Classification Product Code
HST  
Date Received12/26/1985
Decision Date 01/21/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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