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510(k) K173280

Neonatal ConchaSmart Breathing Circuits by Teleflexmedical, Inc. — Product Code BZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2018
Date Received
October 16, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Device Class
Class II
Regulation Number
868.5270
Review Panel
AN
Submission Type

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