The following data is part of a premarket notification filed by Endovations with the FDA for Gastrointestinal Cytology Brush.
| Device ID | K860997 |
| 510k Number | K860997 |
| Device Name: | GASTROINTESTINAL CYTOLOGY BRUSH |
| Classification | Endoscopic Cytology Brush |
| Applicant | ENDOVATIONS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
| Contact | Lester J Lifton |
| Correspondent | Lester J Lifton ENDOVATIONS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
| Product Code | FDX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-18 |
| Decision Date | 1986-05-02 |