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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 WEST 4500 SOUTH, SUITE 9
SALT LAKE CITY,  UT  84107
Applicant Contact R. DOUGLAS JACOB
Correspondent
SORENSON CRITICAL CARE
79 WEST 4500 SOUTH, 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
Recalls CDRH Recalls
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