The following data is part of a premarket notification filed by Mill-rose Laboratory with the FDA for Endoscopic Overtube.
| Device ID | K833268 |
| 510k Number | K833268 |
| Device Name: | ENDOSCOPIC OVERTUBE |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | MILL-ROSE LABORATORY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-21 |
| Decision Date | 1983-10-31 |