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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 K984190
Device Name BACK-ON-TRAC, MODEL 101BOT
Applicant
BACK-ON-TRACK, INC.
344 CLARENDON
ST. CHARLES,  MO  63301
Applicant Contact DAVID A SCIORTINO
Correspondent
BACK-ON-TRACK, INC.
344 CLARENDON
ST. CHARLES,  MO  63301
Correspondent Contact DAVID A SCIORTINO
Regulation Number888.5850
Classification Product Code
HST  
Date Received11/23/1998
Decision Date 03/15/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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