The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Olympus Hyf-p Flexible Hysterofiberscope.
| Device ID | K891451 |
| 510k Number | K891451 |
| Device Name: | OLYMPUS HYF-P FLEXIBLE HYSTEROFIBERSCOPE |
| Classification | Hysteroscope (and Accessories) |
| Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Contact | Joseph R Williams |
| Correspondent | Joseph R Williams OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-15 |
| Decision Date | 1989-10-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170340178 | K891451 | 000 |
| 04953170307089 | K891451 | 000 |
| 04953170058219 | K891451 | 000 |
| 04953170051128 | K891451 | 000 |
| 04953170411571 | K891451 | 000 |
| 04953170411090 | K891451 | 000 |