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510(k) K153470

MADgic Laryngo-Tracheal Mucosal Atomization Device by Teleflex Medical — Product Code CCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2016
Date Received
December 2, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applicator (Laryngo-Tracheal), Topical Anesthesia
Device Class
Class II
Regulation Number
868.5170
Review Panel
AN
Submission Type

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