The following data is part of a premarket notification filed by Zutron Medical with the FDA for Zutron Colonoscope Stiffening Device.
| Device ID | K051068 |
| 510k Number | K051068 |
| Device Name: | ZUTRON COLONOSCOPE STIFFENING DEVICE |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | ZUTRON MEDICAL 9816 PFLUMM RD Lenexa, KS 66215 |
| Contact | Jordan Hartong |
| Correspondent | Jordan Hartong ZUTRON MEDICAL 9816 PFLUMM RD Lenexa, KS 66215 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-26 |
| Decision Date | 2005-07-11 |
| Summary: | summary |