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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cushion, Wheelchair
510(k) Number K890653
Device Name ULTIMA WHEELCHAIR CUSHION
Applicant
Clark Pillow Co., Inc.
Rt. 8 Box 42 I10 W.
Beaumont,  TX  77705
Applicant Contact PAUL M GUILBEAU
Correspondent
Clark Pillow Co., Inc.
Rt. 8 Box 42 I10 W.
Beaumont,  TX  77705
Correspondent Contact PAUL M GUILBEAU
Regulation Number890.3920
Classification Product Code
IMP  
Date Received02/08/1989
Decision Date 02/28/1989
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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