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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 K010402
Device Name SMOOTH-FLO CIRCUIT
Applicant
Hudson Respiratory Care, Inc.
27711 Diaz Rd.
P.O. Box 9020
Temecula,  CA  92589 -9020
Applicant Contact CHARLES MIERKIEWICZ
Correspondent
Hudson Respiratory Care, Inc.
27711 Diaz Rd.
P.O. Box 9020
Temecula,  CA  92589 -9020
Correspondent Contact CHARLES MIERKIEWICZ
Regulation Number868.5450
Classification Product Code
BTT  
Date Received02/12/2001
Decision Date 03/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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