The following data is part of a premarket notification filed by Staar Surgical Co. with the FDA for Elastic Lens Injector Tm.
Device ID | K861085 |
510k Number | K861085 |
Device Name: | ELASTIC LENS INJECTOR TM |
Classification | Lens, Guide, Intraocular |
Applicant | STAAR SURGICAL CO. 1911 WALKER AVE. Monrovia, CA 91016 |
Contact | Robert W Callahan |
Correspondent | Robert W Callahan 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 | 1986-03-21 |
Decision Date | 1986-05-28 |