The following data is part of a premarket notification filed by The Olympus Optical Co. with the FDA for Ues-30 Electrosurgical Unit And It's Associated Accessories.
| Device ID | K023767 |
| 510k Number | K023767 |
| Device Name: | UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | THE OLYMPUS OPTICAL CO. TWO CORPORATE DR. Melville, NY 11747 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler THE OLYMPUS OPTICAL CO. TWO CORPORATE DR. Melville, NY 11747 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-12 |
| Decision Date | 2002-11-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170211772 | K023767 | 000 |
| 14953170211765 | K023767 | 000 |