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FDA 510(k) Application Details - K082009
Device Classification Name
Nebulizer (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K082009
Device Name
Nebulizer (Direct Patient Interface)
Applicant
HSINER CO., LTD.
29201 VIA NORTE
TEMECULA, CA 92591 US
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Contact
TOM SHANKS
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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
07/23/2008
Decision Date
08/22/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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