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510(k) K123640

TX1 TISSUE REMOVAL SYSTEM by Tenex Health — Product Code LFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2013
Date Received
November 26, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Ultrasonic Surgical
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

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