510(k) K851027

SOF. CARE CUSHION & SOF-CARE CUSHION COVER by Gaymar Industries, Inc. — Product Code KIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1985
Date Received
March 12, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cushion, Flotation
Device Class
Class I
Regulation Number
890.3175
Review Panel
PM
Submission Type