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510(k) K202112

Device
Storz Medical Duolith SD1 T-Top & Tower System With C-Actor Sepia Handpiece
Applicant
Storz Medical AG
510(k) number
K202112
Product code
PZL  
Decision
Substantially Equivalent (SESE)
Decision date
2021-02-21
Date received
2020-07-30
Regulation
878.4685
Classification name
Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Pavel Novak
Address
Lohstampfestrasse 8 Tagerwilen CH CH-8274 CH-8274

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PZL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243279DOLORCLAST Focused Shock WavesE.M.S Electro Medical Systems S.A2025-08-13
K250779CS-Pro MEDCurative Sound Therapeutics2025-07-02
K233937OW100SSoftwave/Trt, LLC2024-07-09
K231710OW100SSoftwave/Trt, LLC2023-09-01
K200926OrthoGold 100Tissue Regeneration Technologies, LLC2020-08-28
K191961OrthoGoldTissue Regeneration Technologies2019-11-26
DEN160037dermaPACE SystemSanuwave, Inc.2017-12-28

Legacy Summary#

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FDA Review#

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