The following data is part of a premarket notification filed by Ivera Medical with the FDA for Curos Port Protector.
Device ID | K110826 |
510k Number | K110826 |
Device Name: | CUROS PORT PROTECTOR |
Classification | Cap, Device Disinfectant |
Applicant | IVERA MEDICAL 2731 LOKER AVENUE WEST Carlsbad, CA 92010 |
Contact | Don Canal |
Correspondent | Don Canal IVERA MEDICAL 2731 LOKER AVENUE WEST Carlsbad, CA 92010 |
Product Code | QBP |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-03-24 |
Decision Date | 2011-06-23 |
Summary: | summary |