The following data is part of a premarket notification filed by Medica Holdings, Llc with the FDA for Medicant Mucosal Atomizer.
| Device ID | K172956 |
| 510k Number | K172956 |
| Device Name: | Medicant Mucosal Atomizer |
| Classification | Applicator (laryngo-tracheal), Topical Anesthesia |
| Applicant | Medica Holdings, LLC 5200 Meadows Rd Ste 150 Lake Oswego, OR 97035 |
| Contact | George Reed |
| Correspondent | Paul Dryden Medica Holdings, LLC 5200 Meadows Rd Ste 150 Lake Oswego, OR 97035 |
| Product Code | CCT |
| CFR Regulation Number | 868.5170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-26 |
| Decision Date | 2018-04-06 |
| Summary: | summary |