The following data is part of a premarket notification filed by Annex Medical, Inc. with the FDA for Cytology Brush.
| Device ID | K913248 |
| 510k Number | K913248 |
| Device Name: | CYTOLOGY BRUSH |
| Classification | Endoscopic Cytology Brush |
| Applicant | ANNEX MEDICAL, INC. 7887 FULLER RD. #109 Eden Prairie, MN 55344 |
| Contact | Stuart J Lind |
| Correspondent | Stuart J Lind ANNEX MEDICAL, INC. 7887 FULLER RD. #109 Eden Prairie, MN 55344 |
| Product Code | FDX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-22 |
| Decision Date | 1991-09-30 |