The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Models Ues-10 & Psd-10.
| Device ID | K911904 |
| 510k Number | K911904 |
| Device Name: | MODELS UES-10 & PSD-10 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Contact | Daniel J.dillion |
| Correspondent | Daniel J.dillion OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-29 |
| Decision Date | 1991-07-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170077630 | K911904 | 000 |