The following data is part of a premarket notification filed by Mill-rose Laboratory with the FDA for Colonoscope Guiding Tube Device.
| Device ID | K884857 |
| 510k Number | K884857 |
| Device Name: | COLONOSCOPE GUIDING TUBE DEVICE |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | MILL-ROSE LABORATORY 7310 CORPORATE BLVD. Mentor, OH 44060 -4885 |
| Contact | Mark Kozak |
| Correspondent | Mark Kozak MILL-ROSE LABORATORY 7310 CORPORATE BLVD. Mentor, OH 44060 -4885 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-21 |
| Decision Date | 1989-03-17 |