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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 K780906
Device Name AIR-FLO ALTERNATING PRESSURE PAD SYSTEM
Applicant
Gaymar Industries, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Gaymar Industries, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5550
Classification Product Code
FNM  
Date Received06/02/1978
Decision Date 08/10/1978
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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