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FDA 510(k) Application Details - K072494
Device Classification Name
Nebulizer (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K072494
Device Name
Nebulizer (Direct Patient Interface)
Applicant
MEDEL S.P.A.
112 CAVISTION WAY
CARY, NC 27519 US
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Contact
TERRANCE M O'BRIEN
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
09/05/2007
Decision Date
02/12/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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