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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name humidifier, respiratory gas, (direct patient interface)
510(k) Number K042184
Device Name GOODKNIGHT H20, MODEL M-114600-00
Applicant
MALLINCKRODT DEVELOPPEMENT FRANCE
10 ALLEE PELLETIER DOISY
VILLERS-LES-NANCY,  FR 54601
Applicant Contact MOUSTAFA ANKI
Correspondent
KEMA QUALITY B.V.
4377 COUNTY LINE ROAD
CHALFONT,  PA  18914
Correspondent Contact PATRICIA MURPHY
Regulation Number868.5450
Classification Product Code
BTT  
Date Received08/12/2004
Decision Date 01/10/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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