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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Restraint, Wheelchair, Non-Protective
510(k) Number K802603
Device Name ECONO-FLOAT WHEELCHAIR 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 Number890.3910
Classification Product Code
KID  
Date Received10/21/1980
Decision Date 11/12/1980
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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