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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 K821180
Device Name TRACELON
Applicant
Terumo Medical Corp.
125 Blue Ball Rd.
Elkton,  MD  21921
Correspondent
Terumo Medical Corp.
125 Blue Ball Rd.
Elkton,  MD  21921
Regulation Number868.5730
Classification Product Code
BTR  
Date Received04/27/1982
Decision Date 05/21/1982
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
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