The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Device Electrosurgical Generator Esg-150.
| Device ID | K182587 |
| 510k Number | K182587 |
| Device Name: | Device Electrosurgical Generator ESG-150 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Olympus Winter & Ibe GmbH Kuehnstrasse 61 Hamburg, DE 22045 |
| Contact | Jan-oliver Upmeier |
| Correspondent | Dolan Mills Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-20 |
| Decision Date | 2018-11-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042761085793 | K182587 | 000 |