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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name warmer, infant radiant
510(k) Number K971366
Device Name INCUWARMER
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 Number880.5130
Classification Product Code
FMT  
Date Received04/14/1997
Decision Date 01/05/1998
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
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