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510(k) K122235

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2013
Date Received
July 26, 2012
Clearance Type
Special
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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