Storz Medical Duolith SD1 T-Top & Tower System With C-Actor Sepia Handpiece

Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

Storz Medical AG

The following data is part of a premarket notification filed by Storz Medical Ag with the FDA for Storz Medical Duolith Sd1 T-top & Tower System With C-actor Sepia Handpiece.

Pre-market Notification Details

Device IDK202112
510k NumberK202112
Device Name:Storz Medical Duolith SD1 T-Top & Tower System With C-Actor Sepia Handpiece
ClassificationExtracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Applicant Storz Medical AG Lohstampfestrasse 8 Tagerwilen,  CH Ch-8274
ContactPavel Novak
CorrespondentMichael Dayton
Biomed Research, Inc. 3959 Van Dyke Road, Suite 245 Lutz,  FL  33558
Product CodePZL  
CFR Regulation Number878.4685 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-30
Decision Date2021-02-21

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