The following data is part of a premarket notification filed by Olympus Optical Co., Ltd. with the FDA for Visera Hysterovideoscope Olympus Hyf Type V.
| Device ID | K022445 |
| 510k Number | K022445 |
| Device Name: | VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V |
| Classification | Hysteroscope (and 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 | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-25 |
| Decision Date | 2003-01-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170340185 | K022445 | 000 |
| 04953170411564 | K022445 | 000 |