The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for Vision-sciences Ent-5000 And Ent-5100 Video Ent Scope With Endosheath System, Dpu-5000/dpu-5050 Video Processor.
| Device ID | K072073 |
| 510k Number | K072073 |
| Device Name: | VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR |
| 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 | 2007-07-30 |
| Decision Date | 2007-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00874485002787 | K072073 | 000 |
| 00874485002763 | K072073 | 000 |
| 00874485002671 | K072073 | 000 |
| 00874485000868 | K072073 | 000 |