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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cuff, tracheal tube, inflatable
510(k) Number K142103
Device Name CUFF PILOT, SURE SEAL
Applicant
Teleflex Medical, Inc.
3015 Carrington Mill Blvd
Morrisville,  NC  27560
Applicant Contact PAUL DRYDEN
Correspondent
Teleflex Medical, Inc.
3015 Carrington Mill Blvd
Morrisville,  NC  27560
Correspondent Contact PAUL DRYDEN
Regulation Number868.5750
Classification Product Code
BSK  
Date Received08/01/2014
Decision Date 05/08/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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