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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 K834517
Device Name JAY CUSHION
Applicant
Jay Medical, Ltd.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Jay Medical, Ltd.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number890.3175
Classification Product Code
KIC  
Date Received12/21/1983
Decision Date 01/17/1984
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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