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FDA 510(k) Application Details - K001019
Device Classification Name
Incubator, Neonatal Transport
More FDA Info for this Device
510(K) Number
K001019
Device Name
Incubator, Neonatal Transport
Applicant
HILL-ROM AIR-SHIELDS
330 JACKSONVILLE RD.
HATBORO, PA 19040 US
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Contact
JAMES G CARPENTER
Other 510(k) Applications for this Contact
Regulation Number
880.5410
More FDA Info for this Regulation Number
Classification Product Code
FPL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/30/2000
Decision Date
04/27/2000
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
N
Expedited Review
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