The following data is part of a premarket notification filed by Staar Surgical Co. with the FDA for Microstaar Msi Injector Foam Tip System.
Device ID | K073591 |
510k Number | K073591 |
Device Name: | MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM |
Classification | Folders And Injectors, Intraocular Lens (iol) |
Applicant | STAAR SURGICAL CO. 1911 WALKER AVE. Monrovia, CA 91016 |
Contact | Diana Smith |
Correspondent | Diana Smith STAAR SURGICAL CO. 1911 WALKER AVE. Monrovia, CA 91016 |
Product Code | MSS |
CFR Regulation Number | 886.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-12-20 |
Decision Date | 2008-03-13 |