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FDA 510(k) Application Details - K141214
Device Classification Name
Nebulizer (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K141214
Device Name
Nebulizer (Direct Patient Interface)
Applicant
Teleflex Medical, Inc.
2917 Weck Drive
Research Triangle Park, NC 27709 US
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Contact
JAMES A COCHIE
Other 510(k) Applications for this Contact
Regulation Number
868.5630
More FDA Info for this Regulation Number
Classification Product Code
CAF
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More FDA Info for this Product Code
Date Received
05/12/2014
Decision Date
12/18/2014
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
N
Expedited Review
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