The following data is part of a premarket notification filed by Lenstec Inc. with the FDA for Lenstec Lc Injection System.
Device ID | K161776 |
510k Number | K161776 |
Device Name: | Lenstec LC Injection System |
Classification | Folders And Injectors, Intraocular Lens (iol) |
Applicant | LENSTEC INC. 1765 COMMERCE AVE.N. St. Petersburg, FL 33716 |
Contact | Jimmy Chacko |
Correspondent | Jimmy Chacko LENSTEC INC. 1765 COMMERCE AVE.N. St. Petersburg, FL 33716 |
Product Code | MSS |
CFR Regulation Number | 886.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-06-29 |
Decision Date | 2016-11-29 |
Summary: | summary |