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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/Bronchial, Differential Ventilation (W/Wo Connector)
510(k) Number K201026
Device Name sOLVe Tube
Applicant
HyTek Medical, Inc.
8741 Shirley Ave
Northridge,  CA  91324
Applicant Contact Nir Hoftman
Correspondent
AcKnowledge Regulatory Strategies LLC
2251 San Diego Ave Suite B-257
San Diego,  CA  92110
Correspondent Contact Allison Komiyama
Regulation Number868.5740
Classification Product Code
CBI  
Date Received04/20/2020
Decision Date 08/10/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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