510(k) K882092

CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM by Gaymar Industries, Inc. — Product Code FNM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1988
Date Received
May 19, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mattress, Air Flotation, Alternating Pressure
Device Class
Class II
Regulation Number
880.5550
Review Panel
HO
Submission Type