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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 K031383
Device Name MODEL 780
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 Received05/01/2003
Decision Date 07/07/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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