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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheostomy (W/Wo Connector)
510(k) Number K021764
Device Name RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED
Applicant
Rusch Intl.
Tall Pines Park
Jeffrey,  NH  03452
Applicant Contact RICK LYKINS
Correspondent
Rusch Intl.
Tall Pines Park
Jeffrey,  NH  03452
Correspondent Contact RICK LYKINS
Regulation Number868.5800
Classification Product Code
BTO  
Date Received05/29/2002
Decision Date 07/23/2002
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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