The following data is part of a premarket notification filed by Staar Sugical with the FDA for Disposable Microstaar Injector.
Device ID | K940593 |
510k Number | K940593 |
Device Name: | DISPOSABLE MICROSTAAR INJECTOR |
Classification | Lens, Guide, Intraocular |
Applicant | STAAR SUGICAL 1911 WALKER AVE. Monrovia, CA 91016 |
Contact | Steven L Ziemba |
Correspondent | Steven L Ziemba STAAR SUGICAL 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 | 1994-02-09 |
Decision Date | 1994-09-19 |