The following data is part of a premarket notification filed by Lighthouse Medical, Inc. with the FDA for Cytology Brush.
| Device ID | K954121 |
| 510k Number | K954121 |
| Device Name: | CYTOLOGY BRUSH |
| Classification | Endoscopic Cytology Brush |
| Applicant | LIGHTHOUSE MEDICAL, INC. 100 BEAVER ST. Waltham, MA 02154 |
| Contact | Jenna Andelman |
| Correspondent | Jenna Andelman LIGHTHOUSE MEDICAL, INC. 100 BEAVER ST. Waltham, MA 02154 |
| Product Code | FDX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-01 |
| Decision Date | 1995-10-07 |