The following data is part of a premarket notification filed by Staar Surgical Company with the FDA for Microstaar Injector System Cartridges.
Device ID | K172375 |
510k Number | K172375 |
Device Name: | MicroSTAAR Injector System Cartridges |
Classification | Folders And Injectors, Intraocular Lens (iol) |
Applicant | STAAR Surgical Company 1911 Walker Avenue Monrovia, CA 91016 |
Contact | Kate Ueda |
Correspondent | Kate Ueda STAAR Surgical Company 1911 Walker Avenue Monrovia, CA 91016 |
Product Code | MSS |
CFR Regulation Number | 886.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-08-07 |
Decision Date | 2017-09-06 |
Summary: | summary |