Potenza
Electrosurgical, Cutting & Coagulation & Accessories
Jeisys Medical Incorporated
The following data is part of a premarket notification filed by Jeisys Medical Incorporated with the FDA for Potenza.
Pre-market Notification Details
| Device ID | K192545 |
| 510k Number | K192545 |
| Device Name: | Potenza |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Jeisys Medical Incorporated 307 Daeyung Techno Town 8th; Gamasan-ro 96, Geumcheon-Gu Seoul, KR 08501 |
| Contact | Wonchel Choi |
| Correspondent | Pamela J Weagraff IQVIA 18 Bridie Lane Norfolk, MA 02056 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-16 |
| Decision Date | 2020-02-20 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800020111272 | K192545 | 000 |
| 08800020111104 | K192545 | 000 |
| 08800020111111 | K192545 | 000 |
| 08800020111128 | K192545 | 000 |
| 08800020111135 | K192545 | 000 |
| 08800020111142 | K192545 | 000 |
| 08800020111159 | K192545 | 000 |
| 08800020111258 | K192545 | 000 |
| 08800020111265 | K192545 | 000 |
| 08800020111012 | K192545 | 000 |
Trademark Results [Potenza]
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