The following data is part of a premarket notification filed by Staar Surgical Co. with the FDA for Re-useable Microstaar Injector, Msi-s.
Device ID | K032412 |
510k Number | K032412 |
Device Name: | RE-USEABLE MICROSTAAR INJECTOR, MSI-S |
Classification | Lens, Guide, Intraocular |
Applicant | STAAR SURGICAL CO. 1911 WALKER AVE. Monrovia, CA 91016 |
Contact | Jason K Lyon |
Correspondent | Jason K Lyon STAAR SURGICAL CO. 1911 WALKER AVE. Monrovia, CA 91016 |
Product Code | KYB |
CFR Regulation Number | 886.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-08-05 |
Decision Date | 2004-06-10 |
Summary: | summary |