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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 K913945
Device Name STABILET INFANT RADIANT WARMER MODEL 2000C
Applicant
HILL-ROM, INC.
HIGHWAY 46
BATESVILLE,  TN 
Applicant Contact FORD WILDER
Correspondent
HILL-ROM, INC.
HIGHWAY 46
BATESVILLE,  TN 
Correspondent Contact FORD WILDER
Regulation Number880.5130
Classification Product Code
FMT  
Date Received09/04/1991
Decision Date 02/12/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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