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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 K213028
Device Name Tenax Laser Resistant Endotracheal Tube
Bryan Medical , Inc.
5725 Dragon Way, Suite 300
Cincinnati,  OH  45227
Applicant Contact Andrew J Georgilis
AlvaMed, Inc.
1116 Great Plain Avenue, Suite 1
Needham,  MA  02492
Correspondent Contact Martha Kamrow Russell
Regulation Number868.5730
Classification Product Code
Subsequent Product Code
Date Received09/21/2021
Decision Date 10/21/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No