The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for Modified Endosheath System For Vsi Flexible Cystoscope.
| Device ID | K053560 |
| 510k Number | K053560 |
| Device Name: | MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-21 |
| Decision Date | 2006-03-16 |
| Summary: | summary |