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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 K962123
Device Name AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM
Applicant
Lumex, Inc.
100 Spence St.
Bay Shore,  NY  11706
Applicant Contact JOE Z ANETTI
Correspondent
Lumex, Inc.
100 Spence St.
Bay Shore,  NY  11706
Correspondent Contact JOE Z ANETTI
Regulation Number880.5550
Classification Product Code
FNM  
Date Received05/31/1996
Decision Date 07/18/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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