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510(k) K202112

Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece by Storz Medical AG — Product Code PZL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 21, 2021
Date Received: July 30, 2020
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Device Class: Class II
Regulation Number: 878.4685
Review Panel: SU
Submission Type

Treatment of diabetic foot ulcers