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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 K915368
Device Name SERENA WHEELCHAIR CUSHIONS
Applicant
A & C Medical Supply
7254 Wembley Ter. W.
Toledo,  OH  43617
Applicant Contact CHRISTABELLE PEREIRA
Correspondent
A & C Medical Supply
7254 Wembley Ter. W.
Toledo,  OH  43617
Correspondent Contact CHRISTABELLE PEREIRA
Regulation Number890.3920
Classification Product Code
KNN  
Date Received11/27/1991
Decision Date 12/20/1991
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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