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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 K830352
Device Name REINFORCED SILICONE TRACHEAL TUBE
Applicant
PORTEX, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PORTEX, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5730
Classification Product Code
BTR  
Date Received02/03/1983
Decision Date 03/08/1983
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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