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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 K864765
Device Name MODEL 668, TRACTION SPLINT, ADULT
Applicant
Ferno-Washington, Inc.
70 Weil Way
Wilmington,  OH  45177
Applicant Contact ERIC N BESANKO
Correspondent
Ferno-Washington, Inc.
70 Weil Way
Wilmington,  OH  45177
Correspondent Contact ERIC N BESANKO
Regulation Number888.5850
Classification Product Code
HST  
Date Received12/05/1986
Decision Date 12/17/1986
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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