The following data is part of a premarket notification filed by Mr Associates, Inc. with the FDA for M.r. Assoc. Cytology Brushes.
| Device ID | K800966 |
| 510k Number | K800966 |
| Device Name: | M.R. ASSOC. CYTOLOGY BRUSHES |
| Classification | Endoscopic Cytology Brush |
| Applicant | MR ASSOCIATES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FDX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-23 |
| Decision Date | 1980-05-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816207020546 | K800966 | 000 |
| 10816207020539 | K800966 | 000 |
| 10816207020522 | K800966 | 000 |
| 10816207020515 | K800966 | 000 |
| 10816207020164 | K800966 | 000 |
| 10816207020157 | K800966 | 000 |
| 10816207020140 | K800966 | 000 |
| 10816207020133 | K800966 | 000 |
| 10816207021758 | K800966 | 000 |