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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Suction, Tracheobronchial
510(k) Number K961707
Device Name TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM
Applicant
Sorenson Critical Care
79 W. 4500 S., Suite 9
Salt Lake City,  UT  84107
Applicant Contact R. DOUGLAS JACOB
Correspondent
Sorenson Critical Care
79 W. 4500 S., Suite 9
Salt Lake City,  UT  84107
Correspondent Contact R. DOUGLAS JACOB
Regulation Number868.6810
Classification Product Code
BSY  
Date Received05/02/1996
Decision Date 03/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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