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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 K923946
Device Name CONCHATHERM IV HEATED MOLECULAR HUMIDIFIER
Applicant
Hudson Respiratory Care, Inc.
27711 Diaz Rd.
P.O. Box 9020
Temecula,  CA  92589
Applicant Contact WILLIAM H MURPHY
Correspondent
Hudson Respiratory Care, Inc.
27711 Diaz Rd.
P.O. Box 9020
Temecula,  CA  92589
Correspondent Contact WILLIAM H MURPHY
Regulation Number868.5450
Classification Product Code
BTT  
Date Received08/05/1992
Decision Date 10/18/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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