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510(k) K133173

RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET by Teleflexmedical, Inc. — Product Code JOH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2014
Date Received
October 17, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube Tracheostomy And Tube Cuff
Device Class
Class II
Regulation Number
868.5800
Review Panel
AN
Submission Type

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