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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Applicator (Laryngo-Tracheal), Topical Anesthesia
510(k) Number K153470
Device Name MADgic Laryngo-Tracheal Mucosal Atomization Device
Applicant
Teleflex Medical
3015
Morrisville,  NC  27560
Applicant Contact Kristen Bisanz
Correspondent
Teleflex Medical
3015
Morrisville,  NC  27560
Correspondent Contact Kristen Bisanz
Regulation Number868.5170
Classification Product Code
CCT  
Date Received12/02/2015
Decision Date 08/19/2016
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
Recalls CDRH Recalls
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