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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 K855072
Device Name MAXIMUS CUSHION
Applicant
Jay Medical, Ltd.
805 Walnut
Boulder,  CO  80302
Applicant Contact ERIC JAY
Correspondent
Jay Medical, Ltd.
805 Walnut
Boulder,  CO  80302
Correspondent Contact ERIC JAY
Regulation Number890.3175
Classification Product Code
KIC  
Date Received12/19/1985
Decision Date 03/10/1986
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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