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FDA 510(k) Application Details - K041082
Device Classification Name
Nebulizer (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K041082
Device Name
Nebulizer (Direct Patient Interface)
Applicant
NEWPORT MEDICAL INSTRUMENTS, INC.
760 WEST 16TH ST., BLDG. N
COSTA MESA, CA 92627 US
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Contact
RICHARD WATERS
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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
04/26/2004
Decision Date
09/07/2004
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
N
Expedited Review
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