The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for Flexible Fiberoptic Sigmoidoscope System.
| Device ID | K921690 |
| 510k Number | K921690 |
| Device Name: | FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE SYSTEM |
| Classification | Sigmoidoscope And Accessories, Flexible/rigid |
| Applicant | VISION-SCIENCES, INC. 6 STRATHMORE RD. Natick, MA 01760 |
| Contact | Alan I West |
| Correspondent | Alan I West VISION-SCIENCES, INC. 6 STRATHMORE RD. Natick, MA 01760 |
| Product Code | FAM |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-08 |
| Decision Date | 1992-10-28 |