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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Mattress (Medical Purposes)
510(k) Number K923173
Device Name OBALON COVER
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 Number880.6190
Classification Product Code
FMW  
Date Received06/30/1992
Decision Date 11/06/1992
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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