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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 K913933
Device Name TURNSOFT MATTRESS
Applicant
Turnsoft, Inc.
13420 W. Reese Blvd.
Huntersville,  NC  28078
Applicant Contact ANTHONY F RUCH
Correspondent
Turnsoft, Inc.
13420 W. Reese Blvd.
Huntersville,  NC  28078
Correspondent Contact ANTHONY F RUCH
Regulation Number880.5550
Classification Product Code
FNM  
Date Received09/03/1991
Decision Date 01/10/1992
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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