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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bed, flotation therapy, powered
510(k) Number K970636
Device Name TOTALCARE., MODULAR THERAPY SYSTEM (MTS)
Applicant
HILL-ROM, INC.
1069 STATE ROUTE 46 EAST
BATESVILLE,  IN  47006
Applicant Contact JAMES G CARPENTER
Correspondent
HILL-ROM, INC.
1069 STATE ROUTE 46 EAST
BATESVILLE,  IN  47006
Correspondent Contact JAMES G CARPENTER
Regulation Number890.5170
Classification Product Code
IOQ  
Date Received02/20/1997
Decision Date 08/26/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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