The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for Vision-sciences Ent-3000 Scope.
| Device ID | K050972 |
| 510k Number | K050972 |
| Device Name: | VISION-SCIENCES ENT-3000 SCOPE |
| 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 | 2005-04-18 |
| Decision Date | 2005-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00874485002955 | K050972 | 000 |
| 00874485002947 | K050972 | 000 |
| 00874485001629 | K050972 | 000 |
| 00874485001360 | K050972 | 000 |