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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 K813225
Device Name GEL FLOTATION CUSHION
Applicant
JEFFERSON INDUSTRIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
JEFFERSON INDUSTRIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number890.3175
Classification Product Code
KIC  
Date Received11/10/1981
Decision Date 12/03/1981
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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