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FDA 510(k) Application Details - K032849
Device Classification Name
Nebulizer (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K032849
Device Name
Nebulizer (Direct Patient Interface)
Applicant
AEROGEN, INC.
2071 STIERLIN COURT
MOUNTAIN VIEW, CA 94043 US
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Contact
Nancy E Isaac
Other 510(k) Applications for this Contact
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
09/12/2003
Decision Date
11/21/2003
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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