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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 K963058
Device Name INFANT WARMER SYSTEM
Applicant
OHMEDA MEDICAL
9065 GUILFORD RD.
COLUMBIA,  MD  21046
Applicant Contact ALBERTO F PROFUMO
Correspondent
OHMEDA MEDICAL
9065 GUILFORD RD.
COLUMBIA,  MD  21046
Correspondent Contact ALBERTO F PROFUMO
Regulation Number880.5130
Classification Product Code
FMT  
Date Received08/06/1996
Decision Date 10/01/1996
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
Recalls CDRH Recalls
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