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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K043205
Device Name RUSCH EASY TUBE
Applicant
Teleflex Medical
2345 Waukegan Rd.
Bannockburn,  IL  60015
Applicant Contact LORI HAYS
Correspondent
Teleflex Medical
2345 Waukegan Rd.
Bannockburn,  IL  60015
Correspondent Contact LORI HAYS
Regulation Number868.5730
Classification Product Code
BTR  
Date Received11/19/2004
Decision Date 01/07/2005
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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