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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 K052615
Device Name MEDISIZE GOLD
Applicant
MEDISIZE BV
EDISONSTRAAT 1
HILLEGOM,  NL 2180 AB
Applicant Contact SOPIHA LAM
Correspondent
KEMA QUALITY B.V.
4377 COUNTY LINE ROAD
CHALFONT,  PA  18914
Correspondent Contact J.A. VAN VUGT
Regulation Number868.5450
Classification Product Code
BTT  
Date Received09/23/2005
Decision Date 12/09/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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