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510(k) K213080

T-Edge 10, T-Edge 11 by Tuttnauer , Ltd. — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2022
Date Received
September 23, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Steam
Device Class
Class II
Regulation Number
880.6880
Review Panel
HO
Submission Type

Other clearances by Tuttnauer , Ltd.

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  • K181456 — Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves (July 8, 2019)

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