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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Ac-Powered Adjustable Hospital
510(k) Number K962942
Device Name TOTALCARE
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 Number880.5100
Classification Product Code
FNL  
Date Received07/29/1996
Decision Date 02/03/1997
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
Recalls CDRH Recalls
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