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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 K122885
FOIA Releasable 510(k) K122885
Device Name MEDISIZE GOLD HEATER AND BOOSTER T-PIECE
Applicant
Medisize BV
Prinsessegracht 20
The Hague,  NL
Applicant Contact IFFAT NOOR
Correspondent
Medisize BV
Prinsessegracht 20
The Hague,  NL
Correspondent Contact IFFAT NOOR
Regulation Number868.5450
Classification Product Code
BTT  
Date Received09/20/2012
Decision Date 08/29/2013
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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