The following data is part of a premarket notification filed by Excell Company Llc with the FDA for Excellerator Cervical Collection Device.
| Device ID | K182049 |
| 510k Number | K182049 |
| Device Name: | ExCellerator Cervical Collection Device |
| Classification | Spatula, Cervical, Cytological |
| Applicant | ExCell Company LLC 1540 West Main Street Carmel, IN 46032 |
| Contact | Jim Snyder |
| Correspondent | Jim Snyder ExCell Company LLC 1540 West Main Street Carmel, IN 46032 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-31 |
| Decision Date | 2019-04-25 |