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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 K070714
FOIA Releasable 510(k) K070714
Device Name MEDISIZE GOLD HEATER AND BOOSTER
Applicant
Medisize BV
Edisonstraat 1
Hillegom,  NL 2181 AB
Applicant Contact SOPHIA LAM
Correspondent
Kema Quality B.V.
4377 County Line Rd.
Chalfont,  PA  18914
Correspondent Contact J.A. VAN VUGT
Regulation Number868.5450
Classification Product Code
BTT  
Date Received03/14/2007
Decision Date 04/30/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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