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510(k) K201317

TTBIO EVOCLEAN Ultrasonic Scaler by Ttbio Corp. — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2020
Date Received
May 18, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scaler, Ultrasonic
Device Class
Class II
Regulation Number
872.4850
Review Panel
DE
Submission Type

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