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.
Device ID | K202112 |
510k Number | K202112 |
Device Name: | Storz Medical Duolith SD1 T-Top & Tower System With C-Actor Sepia Handpiece |
Classification | Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers |
Applicant | Storz Medical AG Lohstampfestrasse 8 Tagerwilen, CH Ch-8274 |
Contact | Pavel Novak |
Correspondent | Michael Dayton Biomed Research, Inc. 3959 Van Dyke Road, Suite 245 Lutz, FL 33558 |
Product Code | PZL |
CFR Regulation Number | 878.4685 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-07-30 |
Decision Date | 2021-02-21 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07630039101398 | K202112 | 000 |