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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 K970074
FOIA Releasable 510(k) K970074
Device Name STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D)
Applicant
Hill-Rom, Inc.
1069 State Route 46 E.
Batesville,  IN  47006
Applicant Contact JAMES G CARPENTER
Correspondent
Hill-Rom, Inc.
1069 State Route 46 E.
Batesville,  IN  47006
Correspondent Contact JAMES G CARPENTER
Regulation Number880.5130
Classification Product Code
FMT  
Date Received01/08/1997
Decision Date 04/03/1997
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
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