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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 K063036
Device Name OPUS HC482 DIRECT NASAL MASK
Applicant
Fisher &Paykel Healthcare , Ltd.
15 Maurice Paykel Place
Manukau,  NZ 2013
Applicant Contact JAYANTI KARANDIKAR
Correspondent
Fisher &Paykel Healthcare , Ltd.
15 Maurice Paykel Place
Manukau,  NZ 2013
Correspondent Contact JAYANTI KARANDIKAR
Regulation Number868.5905
Classification Product Code
BZD  
Date Received10/03/2006
Decision Date 12/22/2006
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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