The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for Vision-sciences Model S-v200 Color Mvideo Flexible Sigmoidoscope With Endosheath System.
| Device ID | K964326 |
| 510k Number | K964326 |
| Device Name: | VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM |
| Classification | Sigmoidoscope And Accessories, Flexible/rigid |
| Applicant | VISION-SCIENCES, INC. 6 STRATHMORE RD. Natick, MA 01760 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau 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 | 1996-10-30 |
| Decision Date | 1997-01-03 |
| Summary: | summary |