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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 K962585
Device Name UNIT-MATT 5000 PRESSURE RELIEF SYSTEM
Applicant
United Medical Equipment, Inc.
17 Henry Ave.
Park Ridge,  NJ  07656
Applicant Contact ARRON MEI
Correspondent
United Medical Equipment, Inc.
17 Henry Ave.
Park Ridge,  NJ  07656
Correspondent Contact ARRON MEI
Regulation Number880.5550
Classification Product Code
FNM  
Date Received07/01/1996
Decision Date 01/07/1997
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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