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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
Predetermined Change
Control Plan Authorized		 No
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