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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name heater, breathing system w/wo controller (not humidifier or nebulizer
510(k) Number K173280
Device Name Neonatal ConchaSmart Breathing Circuits
Applicant
Teleflex Medical, Inc
3015 Carrington Mill Blvd-6N
morrisville,  NC  27560
Applicant Contact brian gall
Correspondent
Teleflex Medical, Inc
3015 Carrington Mill Blvd-6N
morrisville,  NC  27560
Correspondent Contact brian gall
Regulation Number868.5270
Classification Product Code
BZE  
Date Received10/16/2017
Decision Date 08/02/2018
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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