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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 K063758
Device Name CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER (REMANUFACTURER), MODEL# 425-00,425-00R
Applicant
Teleflex Medical
2345 Waukegan Rd.
Bannockburn,  IL  60015
Applicant Contact LORI HAYS
Correspondent
Teleflex Medical
2345 Waukegan Rd.
Bannockburn,  IL  60015
Correspondent Contact LORI HAYS
Regulation Number868.5450
Classification Product Code
BTT  
Date Received12/19/2006
Decision Date 04/23/2007
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
Recalls CDRH Recalls
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