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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 K040366
Device Name PRESSURE MANIFOLD, MODEL BC 110
Applicant
Fisher &Paykel Healthcare , Ltd.
15 Maurice Paykel Place
East Tamaki, Auckland,  NZ
Applicant Contact ROBERT PETRY
Correspondent
Fisher &Paykel Healthcare , Ltd.
15 Maurice Paykel Place
East Tamaki, Auckland,  NZ
Correspondent Contact ROBERT PETRY
Regulation Number868.5870
Classification Product Code
CBP  
Date Received02/13/2004
Decision Date 03/04/2004
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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