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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 K190630
Device Name SolidAIRity III Airway Stabilization System
Applicant
Securisyn Medical, LLC
9150 Commerce Center Cir., Suite 135
Highlands Ranch,  CO  80129
Applicant Contact Arthur Kanowitz
Correspondent
Securisyn Medical, LLC
9150 Commerce Center Cir., Suite 135
Highlands Ranch,  CO  80129
Correspondent Contact Arthur Kanowitz
Regulation Number868.5730
Classification Product Code
BTR  
Subsequent Product Code
CBH  
Date Received03/12/2019
Decision Date 10/09/2019
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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