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FDA 510(k) Application Details - K081738
Device Classification Name
Nebulizer (Direct Patient Interface)
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510(K) Number
K081738
Device Name
Nebulizer (Direct Patient Interface)
Applicant
HEALTH & LIFE CO., LTD.
PO BOX 993 A807 EL CAMINO
SUIT C CARMICHAEL, CA 95609 US
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Contact
SAMUEL 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
06/19/2008
Decision Date
09/17/2008
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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