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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixer, Breathing Gases, Anesthesia Inhalation
510(k) Number K050381
Device Name CS MEDICAL TTCF GAS DELIVERY SYSTEM
Applicant
Cs Medical, Inc.
4655 Kirkwood Ct.
Boulder,  CO  80301
Applicant Contact LEWIS WARD
Correspondent
Cs Medical, Inc.
4655 Kirkwood Ct.
Boulder,  CO  80301
Correspondent Contact LEWIS WARD
Regulation Number868.5330
Classification Product Code
BZR  
Date Received02/15/2005
Decision Date 07/13/2005
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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