The following data is part of a premarket notification filed by Ivera Medical, Inc. with the FDA for Curos Tip.
| Device ID | K121171 |
| 510k Number | K121171 |
| Device Name: | CUROS TIP |
| Classification | Cap, Device Disinfectant |
| Applicant | IVERA MEDICAL, INC. 2731 LOKER AVENUE WEST Carlsbad, CA 92010 |
| Contact | Don Canal |
| Correspondent | Don Canal IVERA MEDICAL, INC. 2731 LOKER AVENUE WEST Carlsbad, CA 92010 |
| Product Code | QBP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-17 |
| Decision Date | 2012-11-26 |
| Summary: | summary |