The following data is part of a premarket notification filed by Staar Surgical Co. with the FDA for Ultrakit.
Device ID | K831172 |
510k Number | K831172 |
Device Name: | ULTRAKIT |
Classification | Unit, Phacofragmentation |
Applicant | STAAR SURGICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HQC |
CFR Regulation Number | 886.4670 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-04-11 |
Decision Date | 1983-06-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ULTRAKIT 77368219 3556313 Live/Registered |
AGILENT TECHNOLOGIES, INC. 2008-01-10 |
ULTRAKIT 74580325 1994476 Dead/Cancelled |
ULTRA Scientific, Incorporated 1994-09-29 |
ULTRAKIT 73556443 1387442 Dead/Cancelled |
ANTON/BAUER, INC. 1985-09-03 |