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FDA 510(k) Application Details - K040910
Device Classification Name
Incubator, Neonatal
More FDA Info for this Device
510(K) Number
K040910
Device Name
Incubator, Neonatal
Applicant
CHOONGWAE MEDICAL CORP.
1733 CANTON LANE
MARIETTA, GA 30062 US
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Contact
RONALD D ARKIN
Other 510(k) Applications for this Contact
Regulation Number
880.5400
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Classification Product Code
FMZ
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More FDA Info for this Product Code
Date Received
04/08/2004
Decision Date
04/21/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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