The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for Vision-sciences Model B-f100 Bronchoscope With Model Bs-f21 Disposable Endosheath.
| Device ID | K963795 |
| 510k Number | K963795 |
| Device Name: | VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | VISION-SCIENCES, INC. 6 STRATHMORE RD. Natick, MA 01760 |
| Contact | Pamela L Papineau |
| Correspondent | Pamela L Papineau VISION-SCIENCES, INC. 6 STRATHMORE RD. Natick, MA 01760 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-23 |
| Decision Date | 1996-12-23 |
| Summary: | summary |