The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Olympus Hysteroresectoscope.
| Device ID | K897003 |
| 510k Number | K897003 |
| Device Name: | OLYMPUS HYSTERORESECTOSCOPE |
| Classification | Hysteroscope (and Accessories) |
| Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Contact | Daniel J Dillon |
| Correspondent | Daniel J Dillon 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 | 1989-12-18 |
| Decision Date | 1990-03-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14042761001004 | K897003 | 000 |
| 04042761006507 | K897003 | 000 |
| 04042761006514 | K897003 | 000 |
| 04042761006545 | K897003 | 000 |
| 04042761006651 | K897003 | 000 |
| 04042761004817 | K897003 | 000 |
| 04042761004848 | K897003 | 000 |
| 04042761020831 | K897003 | 000 |
| 04042761020848 | K897003 | 000 |
| 04042761020862 | K897003 | 000 |
| 04042761020879 | K897003 | 000 |
| 04042761020886 | K897003 | 000 |
| 04042761006668 | K897003 | 000 |