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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 K190878
Device Name Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff
Applicant
Salter Labs, Inc.
2365 Camino Vida Roble
Carlsbad,  CA  92011
Applicant Contact Mara Caler
Correspondent
Salter Labs
2365 Camino Vida Roble
Carlsbad,  CA  92011
Correspondent Contact Paul Dryden
Regulation Number868.5730
Classification Product Code
BTR  
Date Received04/04/2019
Decision Date 01/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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