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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 K934465
Device Name DIC TRACHEOSTOMY TUBE AND PORTEX BLUE LINE
Applicant
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
15 KIT ST.
KEENE,  NH  03431
Applicant Contact TIMOTHY J TALCOTT
Correspondent
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
15 KIT ST.
KEENE,  NH  03431
Correspondent Contact TIMOTHY J TALCOTT
Regulation Number868.5730
Classification Product Code
BTR  
Date Received09/13/1993
Decision Date 01/14/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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