The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for Flexible Nasopharyngo-laryngoscope And Endosheath.
| Device ID | K942265 |
| 510k Number | K942265 |
| Device Name: | FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE AND ENDOSHEATH |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | VISION-SCIENCES, INC. 6 STRATHMORE RD. Natick, MA 01760 |
| Contact | Debbie Iampietro |
| Correspondent | Debbie Iampietro VISION-SCIENCES, INC. 6 STRATHMORE RD. Natick, MA 01760 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-09 |
| Decision Date | 1995-12-22 |