The following data is part of a premarket notification filed by Cosmo Technologies, Ltd. with the FDA for Sic 8000.
| Device ID | K150852 |
| 510k Number | K150852 |
| Device Name: | SIC 8000 |
| Classification | Submucosal Injection Agent |
| Applicant | COSMO TECHNOLOGIES, LTD. 42-43 AMIENS STREET Dublin 1, IE |
| Contact | Richard Jones |
| Correspondent | Steven A. Kradjian CONVENTUS BIOMEDICAL SOLUTIONS, INC. 5414 OBERLIN DRIVE, SUITE 130 San Diego, CA 92121 |
| Product Code | PLL |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-31 |
| Decision Date | 2015-09-03 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SIC 8000 86655317 5004737 Live/Registered |
Cosmo Technologies Limited 2015-06-08 |