The following data is part of a premarket notification filed by Lenstec, Inc. with the FDA for Lenstec Intraocular Lens (iol) Injection System.
| Device ID | K060533 |
| 510k Number | K060533 |
| Device Name: | LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM |
| Classification | Folders And Injectors, Intraocular Lens (iol) |
| Applicant | LENSTEC, INC. 2870 SCHERER DR., SUITE 300 St. Petersburg, FL 33716 |
| Contact | Luis Ruiz |
| Correspondent | Luis Ruiz LENSTEC, INC. 2870 SCHERER DR., SUITE 300 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 | 2006-02-28 |
| Decision Date | 2006-04-14 |
| Summary: | summary |