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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chair, With Casters
510(k) Number K802745
Device Name FOLDING SHOWER-COMMODE CHAIR
Applicant
Winco Winfield Co., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Winco Winfield Co., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number890.3100
Classification Product Code
INM  
Date Received11/03/1980
Decision Date 11/19/1980
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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