The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for Protective Sheath For Flexible Nasophary/larygnos.
| Device ID | K933247 |
| 510k Number | K933247 |
| Device Name: | PROTECTIVE SHEATH FOR FLEXIBLE NASOPHARY/LARYGNOS |
| 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 | 1993-07-02 |
| Decision Date | 1993-11-22 |