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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 K200761
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 Ian Broome
Regulation Number868.5730
Classification Product Code
Subsequent Product Code
Date Received03/24/2020
Decision Date 11/25/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No