The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for Vision-sciences Cst-2000 Flexible Cystoscope With Slide-on Endosheath System.
| Device ID | K040215 |
| 510k Number | K040215 |
| Device Name: | VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | VISION-SCIENCES, INC. 5 WHITCOMB AVE. Ayer, MA 01432 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau VISION-SCIENCES, INC. 5 WHITCOMB AVE. Ayer, MA 01432 |
| Product Code | FAJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-30 |
| Decision Date | 2004-04-15 |
| Summary: | summary |