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FDA 510(k) Application Details - DEN170055
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN170055
Device Name
Retrograde Intubation Set
Applicant
Cook Incorporated
750 Daniels Way
Bloomington, ID 47404 US
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Contact
Hui Ouyang
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Regulation Number
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Classification Product Code
QCX
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Date Received
09/25/2017
Decision Date
12/12/2018
Decision
DENG -
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
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