The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for Endosheath Systems For Use With Vision-sciences Tne Scope.
| Device ID | K071903 |
| 510k Number | K071903 |
| Device Name: | ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-10 |
| Decision Date | 2007-08-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994657798 | K071903 | 000 |
| 20613994657781 | K071903 | 000 |
| 20874485000756 | K071903 | 000 |
| 20874485000749 | K071903 | 000 |