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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K033087
Device Name ORACLE ORAL MASK, MODEL HC451A
Applicant
Fisher &Paykel Healthcare , Ltd.
15 Maurice Paykel Place
East Tamaki, Auckland,  NZ
Applicant Contact JAMES THOMPSON
Correspondent
Fisher &Paykel Healthcare , Ltd.
15 Maurice Paykel Place
East Tamaki, Auckland,  NZ
Correspondent Contact JAMES THOMPSON
Regulation Number868.5905
Classification Product Code
BZD  
Date Received09/29/2003
Decision Date 01/14/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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