The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for Vision System Colonscope.
| Device ID | K943895 |
| 510k Number | K943895 |
| Device Name: | VISION SYSTEM COLONSCOPE |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | VISION-SCIENCES, INC. 6 STRATHMORE RD. Natick, MA 01760 |
| Contact | Debbie Iampietro |
| Correspondent | Debbie Iampietro VISION-SCIENCES, INC. 6 STRATHMORE RD. Natick, MA 01760 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-09 |
| Decision Date | 1995-02-03 |