The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Urology And Gynecology Hardware System.
| Device ID | K040390 |
| 510k Number | K040390 |
| Device Name: | STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEM |
| Classification | Hysteroscope (and Accessories) |
| Applicant | Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
| Contact | Christopher L Cook |
| Correspondent | Christopher L Cook Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
| Product Code | HIH |
| Subsequent Product Code | FAJ |
| Subsequent Product Code | FAS |
| Subsequent Product Code | KQT |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-17 |
| Decision Date | 2004-05-17 |
| Summary: | summary |