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FDA 510(k) Application Details - K173770
Device Classification Name
Valve, Non-Rebreathing
More FDA Info for this Device
510(K) Number
K173770
Device Name
Valve, Non-Rebreathing
Applicant
Fisher & Paykel Healthcare Limited
15 Maurice Paykel Place,
East Tamaki
Auckland 2013 NZ
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Contact
Adele Bindon
Other 510(k) Applications for this Contact
Regulation Number
868.5870
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Classification Product Code
CBP
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More FDA Info for this Product Code
Date Received
12/11/2017
Decision Date
04/05/2019
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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