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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Components, Wheelchair
510(k) Number K855181
Device Name COMFORTEX WHEELCHAIR CUSHION
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 Number890.3920
Classification Product Code
KNN  
Date Received12/26/1985
Decision Date 01/13/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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