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FDA 510(k) Application Details - K062811
Device Classification Name
Nebulizer (Direct Patient Interface)
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510(K) Number
K062811
Device Name
Nebulizer (Direct Patient Interface)
Applicant
LIFE OUTCOMES, INC.
3957 BLUE PINE CIRCLE
HIGHLANDS RANCH, CO 80126-8077 US
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Contact
CHARLES M HART
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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
09/19/2006
Decision Date
12/20/2006
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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