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FDA 510(k) Application Details - K052663
Device Classification Name
Apparatus, Nitric Oxide, Backup Delivery
More FDA Info for this Device
510(K) Number
K052663
Device Name
Apparatus, Nitric Oxide, Backup Delivery
Applicant
INO THERAPEUTICS
7601-B MURPHY DRIVE
MIDDLETON, WI 53562 US
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Contact
FREDERICK MONTGOMERY
Other 510(k) Applications for this Contact
Regulation Number
868.5165
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Classification Product Code
MRO
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More FDA Info for this Product Code
Date Received
09/27/2005
Decision Date
11/04/2005
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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