The following data is part of a premarket notification filed by Mill-rose Laboratory with the FDA for Microbiology Specimen Brush.
| Device ID | K820771 |
| 510k Number | K820771 |
| Device Name: | MICROBIOLOGY SPECIMEN BRUSH |
| Classification | Brush, Biopsy, Bronchoscope (non-rigid) |
| Applicant | MILL-ROSE LABORATORY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BTG |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-23 |
| Decision Date | 1982-05-03 |