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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K961150
Device Name DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULA
Applicant
Hudson Respiratory Care, Inc.
27711 Diaz Rd.
Temecula,  CA  92390
Applicant Contact ARDEN MORLEY
Correspondent
Hudson Respiratory Care, Inc.
27711 Diaz Rd.
Temecula,  CA  92390
Correspondent Contact ARDEN MORLEY
Regulation Number868.1400
Classification Product Code
CCK  
Date Received03/22/1996
Decision Date 09/10/1996
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
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