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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, Oxygen, Gaseous-Phase
510(k) Number K041773
Device Name OXYGEN MEDICELS, CITICELS
Applicant
City Technology Limited
Walton Rd.
Portsmouth,Hampshire England,  GB PO6 1SZ
Applicant Contact DEBRA WALLACE
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFF D RONGERO
Regulation Number868.1720
Classification Product Code
CCL  
Date Received07/01/2004
Decision Date 07/15/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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