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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Bacterial, Breathing-Circuit
510(k) Number K050927
Device Name RT019 INSPIRATORY/EXPIRATORY FILTER
Applicant
Fisher &Paykel Healthcare , Ltd.
15 Maurice Paykel Place
P.O. Box 14-348, Panmure
East Tamaki, Auckland,  NZ
Applicant Contact RENETA MONEY
Correspondent
Fisher &Paykel Healthcare , Ltd.
15 Maurice Paykel Place
P.O. Box 14-348, Panmure
East Tamaki, Auckland,  NZ
Correspondent Contact RENETA MONEY
Regulation Number868.5260
Classification Product Code
CAH  
Date Received04/13/2005
Decision Date 08/01/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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