The following data is part of a premarket notification filed by Circon Video with the FDA for Adult Resectoscope.
| Device ID | K890328 |
| 510k Number | K890328 |
| Device Name: | ADULT RESECTOSCOPE |
| Classification | Hysteroscope (and Accessories) |
| Applicant | CIRCON VIDEO 300 STILLWATER AVE. P.O. BOX BOX 1971 Stanford, CT 06904 -1971 |
| Contact | Taylor, Pe |
| Correspondent | Taylor, Pe CIRCON VIDEO 300 STILLWATER AVE. P.O. BOX BOX 1971 Stanford, CT 06904 -1971 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-23 |
| Decision Date | 1990-02-06 |