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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
Recalls CDRH Recalls
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