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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 K103786
Device Name ZEST PETITE NASAL MASK
Applicant
FISHER & PAYKEL HEALTHCARE, LTD.
15 MAURICE PAYKEL PLACE
EAST TAMAKI, AUCKLAND,  NZ 2013
Applicant Contact TINA MASON
Correspondent
FISHER & PAYKEL HEALTHCARE, LTD.
15 MAURICE PAYKEL PLACE
EAST TAMAKI, AUCKLAND,  NZ 2013
Correspondent Contact TINA MASON
Regulation Number868.5905
Classification Product Code
BZD  
Date Received12/27/2010
Decision Date 03/24/2011
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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