The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for Tne-2000 Esophagoscope With Ecs-d Endosheath System.
| Device ID | K031786 |
| 510k Number | K031786 |
| Device Name: | TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM |
| Classification | Esophagoscope (flexible Or 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 | EOX |
| CFR Regulation Number | 874.4710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-10 |
| Decision Date | 2003-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994394631 | K031786 | 000 |
| 20613994394570 | K031786 | 000 |
| 20613994394563 | K031786 | 000 |
| 00763000034238 | K031786 | 000 |