The following data is part of a premarket notification filed by Hobbs Medical, Inc. with the FDA for Pulmonary Cytology Brush.
| Device ID | K182927 |
| 510k Number | K182927 |
| Device Name: | Pulmonary Cytology Brush |
| Classification | Brush, Biopsy, Bronchoscope (non-rigid) |
| Applicant | Hobbs Medical, Inc. 8 Spring Street Stafford Springs, CT 06076 |
| Contact | Carlos O. Acosta |
| Correspondent | Carlos O. Acosta Hobbs Medical, Inc. 8 Spring Street Stafford Springs, CT 06076 |
| Product Code | BTG |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-22 |
| Decision Date | 2020-02-07 |