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FDA 510(k) Application Details - K041418
Device Classification Name
Nebulizer (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K041418
Device Name
Nebulizer (Direct Patient Interface)
Applicant
Cardinal Health
1500 WAUKEGAN ROAD
MCGAW PARK, IL 60085 US
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Contact
LAVENIA FORD
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Regulation Number
868.5630
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Classification Product Code
CAF
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More FDA Info for this Product Code
Date Received
05/27/2004
Decision Date
06/10/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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