The following data is part of a premarket notification filed by Global Endoscopy, Inc. with the FDA for Cystoscopes.
| Device ID | K003807 |
| 510k Number | K003807 |
| Device Name: | CYSTOSCOPES |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | GLOBAL ENDOSCOPY, INC. 914 W. ESTES CT. Schaumburg, IL 60193 -4426 |
| Contact | Nick Mircea |
| Correspondent | Nick Mircea GLOBAL ENDOSCOPY, INC. 914 W. ESTES CT. Schaumburg, IL 60193 -4426 |
| Product Code | FAJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-08 |
| Decision Date | 2001-02-22 |