The following data is part of a premarket notification filed by Sheathing Technologies, Inc. with the FDA for Colonoscope/sigmoidoscope Sheathes.
| Device ID | K100966 |
| 510k Number | K100966 |
| Device Name: | COLONOSCOPE/SIGMOIDOSCOPE SHEATHES |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | SHEATHING TECHNOLOGIES, INC. 18431 TECHNOLOGY DR. Morgan Hill, CA 95037 |
| Contact | Jennifer Downing |
| Correspondent | Jennifer Downing SHEATHING TECHNOLOGIES, INC. 18431 TECHNOLOGY DR. Morgan Hill, CA 95037 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-08 |
| Decision Date | 2010-08-03 |
| Summary: | summary |