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510(k) K212049

Oclet TDS 1000 by Tendonova Corporation — Product Code LFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2022
Date Received
June 30, 2021
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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