The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for Vision Sciences Model Ent-2000v Flexible Nasopharyngo-laryngoscope.
| Device ID | K040984 |
| 510k Number | K040984 |
| Device Name: | VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE |
| 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 | 2004-04-15 |
| Decision Date | 2004-04-27 |
| Summary: | summary |