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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name valve, non-rebreathing
510(k) Number K173770
Device Name OJR215 Pressure Relief Manifold
Applicant
Fisher & Paykel Healthcare Limited
15 Maurice Paykel Place,
East Tamaki
Auckland,  NZ 2013
Applicant Contact Adele Bindon
Correspondent
Fisher & Paykel Healthcare Limited
15 Maurice Paykel Place,
East Tamaki
Auckland,  NZ 2013
Correspondent Contact Adele Bindon
Regulation Number868.5870
Classification Product Code
CBP  
Date Received12/11/2017
Decision Date 04/05/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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