The following data is part of a premarket notification filed by Olympus Optical Co., Ltd. with the FDA for Olympus Psd-20 Electrosurgical System And Its Associated Accessories.
| Device ID | K023280 |
| 510k Number | K023280 |
| Device Name: | OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | OLYMPUS OPTICAL CO., LTD. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS OPTICAL CO., LTD. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-01 |
| Decision Date | 2002-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170062872 | K023280 | 000 |
| 04953170048548 | K023280 | 000 |
| 04953170025693 | K023280 | 000 |