The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for Vision System Upper G.i. Exdoscope.
| Device ID | K943715 |
| 510k Number | K943715 |
| Device Name: | VISION SYSTEM UPPER G.I. EXDOSCOPE |
| Classification | Gastroscope 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 | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-01 |
| Decision Date | 1995-02-24 |