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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 K090697
Device Name MODIFICATION TO: GIRAFFE AND PANDA WARMER
Applicant
OHMEDA MEDICAL
8880 GORMAN RD.
LAUREL,  MD  20723
Applicant Contact AGATA SMIEJA
Correspondent
OHMEDA MEDICAL
8880 GORMAN RD.
LAUREL,  MD  20723
Correspondent Contact AGATA SMIEJA
Regulation Number880.5130
Classification Product Code
FMT  
Date Received03/17/2009
Decision Date 04/16/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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