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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K020665
Device Name HI-OX
Applicant
Sensor Medics Corp.
22705 Savi Ranch Pkwy.
Yorba Linda,  CA  92887 -4645
Applicant Contact EARL W DRAPER
Correspondent
Sensor Medics Corp.
22705 Savi Ranch Pkwy.
Yorba Linda,  CA  92887 -4645
Correspondent Contact EARL W DRAPER
Regulation Number868.5870
Classification Product Code
CBP  
Subsequent Product Code
KGB  
Date Received03/01/2002
Decision Date 07/30/2002
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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