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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 K953069
Device Name AMERIMED AS110
Applicant
Amerimed Systems L.C.
900 N. Polk St., #152
Desoto,  TX  75115
Applicant Contact DARRELL R BRANHAGEN
Correspondent
Amerimed Systems L.C.
900 N. Polk St., #152
Desoto,  TX  75115
Correspondent Contact DARRELL R BRANHAGEN
Regulation Number880.5550
Classification Product Code
FNM  
Date Received06/30/1995
Decision Date 08/31/1995
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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