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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 K083832
Device Name ZEST NASAL MASK
Applicant
FISHER & PAYKEL HEALTHCARE, LTD.
15 MAURICE PAYKEL PLACE
P.O. BOX 14348
EAST TAMAKI,  NZ
Applicant Contact TINA MASON
Correspondent
FISHER & PAYKEL HEALTHCARE, LTD.
15 MAURICE PAYKEL PLACE
P.O. BOX 14348
EAST TAMAKI,  NZ
Correspondent Contact TINA MASON
Regulation Number868.5905
Classification Product Code
BZD  
Date Received12/23/2008
Decision Date 03/16/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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