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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 Cedex,  FR 54601
Applicant Contact MOUSTAFA ANKI
Correspondent
Kema Quality B.V.
4377 County Line Rd.
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
Predetermined Change
Control Plan Authorized		 No
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