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FDA 510(k) Application Details - K053360
Device Classification Name
Nebulizer (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K053360
Device Name
Nebulizer (Direct Patient Interface)
Applicant
AEROVECTRX CORPORATION
6224 SAMOA WAY
CARMICHAEL, CA 95608 US
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Contact
DAVE PIPER
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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
12/02/2005
Decision Date
03/23/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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