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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Cushion, Flotation
510(k) Number K872739
Device Name SAFE-SEAT, LOW-PROFILE WHEELCHAIR CUSHION
Applicant
D.A. Schulman, Inc.
7701 Newton Ave. N.
Brooklyn Park,  MN  55444
Applicant Contact DAVID A SCHULMAN
Correspondent
D.A. Schulman, Inc.
7701 Newton Ave. N.
Brooklyn Park,  MN  55444
Correspondent Contact DAVID A SCHULMAN
Regulation Number890.3175
Classification Product Code
KIC  
Date Received07/09/1987
Decision Date 07/30/1987
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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