The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for Modification To Vision Sciences Endosheath System.
| Device ID | K024095 |
| 510k Number | K024095 |
| Device Name: | MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM |
| Classification | Nasopharyngoscope (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 | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-12 |
| Decision Date | 2003-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994394808 | K024095 | 000 |
| 20613994394792 | K024095 | 000 |
| 20613994394785 | K024095 | 000 |
| 20613994394778 | K024095 | 000 |
| 20613994394761 | K024095 | 000 |
| 20613994394754 | K024095 | 000 |
| 20613994394747 | K024095 | 000 |
| 20613994394655 | K024095 | 000 |