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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 K062664
Device Name HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004
Applicant
Apex Medical Corp.
# 9, Minsheng St.
Tucheng City, Taipei County,  TW 236
Applicant Contact ALAN CHANG
Correspondent
Apex Medical Corp.
# 9, Minsheng St.
Tucheng City, Taipei County,  TW 236
Correspondent Contact ALAN CHANG
Regulation Number868.5450
Classification Product Code
BTT  
Date Received09/07/2006
Decision Date 12/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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