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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 K871006
Device Name EDCOOL AND EDCOOL JR. INSTANT COLD PACK
Applicant
Advantage Credit Services, Inc.
P.O. Box 768
Kansas City,  MO  64141
Applicant Contact HOWARD J GERSON
Correspondent
Advantage Credit Services, Inc.
P.O. Box 768
Kansas City,  MO  64141
Correspondent Contact HOWARD J GERSON
Regulation Number890.3920
Classification Product Code
IMP  
Date Received03/13/1987
Decision Date 03/25/1987
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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