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FDA 510(k) Application Details - K093260
Device Classification Name
Apparatus, Nitric Oxide Delivery
More FDA Info for this Device
510(K) Number
K093260
Device Name
Apparatus, Nitric Oxide Delivery
Applicant
INTERNATIONAL BIOMEDICAL, LTD.
8508 CROSS PARK DR.
AUSTIN, TX 78754 US
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Contact
AMY PIEPER
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Regulation Number
868.5165
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Classification Product Code
MRN
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More FDA Info for this Product Code
Date Received
10/19/2009
Decision Date
12/16/2009
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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