The following data is part of a premarket notification filed by Olympus Optical Co., Ltd. with the FDA for Disposable Guidewire, Models G-205-3545s & G-205-3545a.
| Device ID | K021179 |
| 510k Number | K021179 |
| Device Name: | DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A |
| Classification | Endoscopic Guidewire, Gastroenterology-urology |
| 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 | OCY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-15 |
| Decision Date | 2002-07-05 |
| Summary: | summary |