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 |