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 |