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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cuff, tracheal tube, inflatable
510(k) Number K192611
Device Name Cuffix
Biovo Technologies Ltd.
23 HaMelacha St
ROsh HaAyin,  IL 4809173
Applicant Contact Barbara Sokoletsky
ProMedoss, Inc.
3521 Hatwynn Rd.
Charlotte,  NC  28269
Correspondent Contact Bosmat Friedman
Regulation Number868.5750
Classification Product Code
Date Received09/20/2019
Decision Date 08/13/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No