The following data is part of a premarket notification filed by Staar Japan with the FDA for Microstaar Msi Injector System Cartridge.
Device ID | K101782 |
510k Number | K101782 |
Device Name: | MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE |
Classification | Folders And Injectors, Intraocular Lens (iol) |
Applicant | STAAR JAPAN 1911 WALKER AVENUE Monrovia, CA 91016 |
Contact | Jack Coggan |
Correspondent | Jack Coggan STAAR JAPAN 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 | 2010-06-25 |
Decision Date | 2010-12-22 |
Summary: | summary |