The following data is part of a premarket notification filed by Lenstec, Inc. with the FDA for Lenstec Lc Injection System.
| Device ID | K122848 |
| 510k Number | K122848 |
| Device Name: | LENSTEC LC INJECTION SYSTEM |
| Classification | Folders And Injectors, Intraocular Lens (iol) |
| Applicant | LENSTEC, INC. 1765 Commerce Ave N Saint Petersburg, FL 33716 |
| Contact | Jimmy Chacko |
| Correspondent | John Howlett BSI HEALTHCARE KITEMARK COURT, DAVY AVENUE KNOWLHILL Milton Keynes, GB Mk5 8pp |
| Product Code | MSS |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-09-18 |
| Decision Date | 2013-10-18 |
| Summary: | summary |