The following data is part of a premarket notification filed by American Endoscopy, Inc. with the FDA for Sterile Cytology Brushes.
| Device ID | K820259 |
| 510k Number | K820259 |
| Device Name: | STERILE CYTOLOGY BRUSHES |
| Classification | Brush, Biopsy, General & Plastic Surgery |
| Applicant | AMERICAN ENDOSCOPY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GEE |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-01 |
| Decision Date | 1982-03-05 |