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FDA 510(k) Application Details - K160109
Device Classification Name
Holding Chambers, Direct Patient Interface
More FDA Info for this Device
510(K) Number
K160109
Device Name
Holding Chambers, Direct Patient Interface
Applicant
THAYER MEDICAL CORPORATION
4575 SOUTH PALO VERDE ROAD
SUITE 337
TUCSON, AZ 85714 US
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Contact
MEGHAN MCGOVERN
Other 510(k) Applications for this Contact
Regulation Number
868.5630
More FDA Info for this Regulation Number
Classification Product Code
NVP
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More FDA Info for this Product Code
Date Received
01/19/2016
Decision Date
05/19/2017
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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