The following data is part of a premarket notification filed by Mill-rose Laboratory with the FDA for Mill-rose Scope Cleaning Brush.
| Device ID | K946293 |
| 510k Number | K946293 |
| Device Name: | MILL-ROSE SCOPE CLEANING BRUSH |
| Classification | Accessories, Cleaning Brushes, For Endoscope |
| Applicant | MILL-ROSE LABORATORY 7310 CORPORATE BLVD. Mentor, OH 44060 -4885 |
| Contact | Alan C Poje |
| Correspondent | Alan C Poje MILL-ROSE LABORATORY 7310 CORPORATE BLVD. Mentor, OH 44060 -4885 |
| Product Code | MNL |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-27 |
| Decision Date | 1995-02-16 |