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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
Predetermined Change
Control Plan Authorized		 No
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