The following data is part of a premarket notification filed by Schott Fiber Optics, Inc. with the FDA for Flexible Immersible Hysteroscope.
| Device ID | K892390 |
| 510k Number | K892390 |
| Device Name: | FLEXIBLE IMMERSIBLE HYSTEROSCOPE |
| Classification | Hysteroscope (and Accessories) |
| Applicant | SCHOTT FIBER OPTICS, INC. 122 CHARLTON ST. Southbridge, MA 01550 |
| Contact | Richard F Taylor |
| Correspondent | Richard F Taylor SCHOTT FIBER OPTICS, INC. 122 CHARLTON ST. Southbridge, MA 01550 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-07 |
| Decision Date | 1990-02-02 |