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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 K860037
Device Name SUSPENDER ORTHOPEDIC SUSPENSION DEVICE
Applicant
Comfortex, Inc.
420 Main St.
Winona,  MN  55987
Applicant Contact DONALD M SALYARDS
Correspondent
Comfortex, Inc.
420 Main St.
Winona,  MN  55987
Correspondent Contact DONALD M SALYARDS
Regulation Number888.5850
Classification Product Code
HST  
Date Received01/06/1986
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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