The following data is part of a premarket notification filed by Olympus Optical Co., Ltd. with the FDA for Olympus Psd-20 Electrosurgical System & Its Associated Accessories.
| Device ID | K021852 |
| 510k Number | K021852 |
| Device Name: | OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM & 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 | 2002-06-05 |
| Decision Date | 2003-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170078361 | K021852 | 000 |
| 04953170077692 | K021852 | 000 |
| 04953170077685 | K021852 | 000 |
| 04953170077647 | K021852 | 000 |
| 04953170027451 | K021852 | 000 |
| 04953170026317 | K021852 | 000 |
| 04953170025693 | K021852 | 000 |
| 04953170025594 | K021852 | 000 |