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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mattress, Air Flotation, Alternating Pressure
510(k) Number K882644
Device Name HUNTLEIGH DOUBLE BUBBLE AIR-O-PAD-AOP5
Applicant
Huntleigh Technology, Inc.
227 Rte. 33 E.
Manalapan,  NJ  07726
Applicant Contact JAMES BRITTON
Correspondent
Huntleigh Technology, Inc.
227 Rte. 33 E.
Manalapan,  NJ  07726
Correspondent Contact JAMES BRITTON
Regulation Number880.5550
Classification Product Code
FNM  
Date Received06/27/1988
Decision Date 08/10/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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