The following data is part of a premarket notification filed by Corin Usa with the FDA for Lars Ac Band Device.
| Device ID | K190143 |
| 510k Number | K190143 |
| Device Name: | LARS AC Band Device |
| Classification | Washer, Bolt Nut |
| Applicant | Corin USA 12750 Citrus Park Lane, Suite 120 Tampa, FL 33625 |
| Contact | Lucinda Gerber |
| Correspondent | Lucinda Gerber Corin USA 12750 Citrus Park Lane, Suite 120 Tampa, FL 33625 |
| Product Code | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-29 |
| Decision Date | 2019-11-04 |