The following data is part of a premarket notification filed by Lenstec, Inc. with the FDA for Fluid Isolation Device.
| Device ID | K091915 |
| 510k Number | K091915 |
| Device Name: | FLUID ISOLATION DEVICE |
| Classification | Unit, Phacofragmentation |
| 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 | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-30 |
| Decision Date | 2009-10-27 |
| Summary: | summary |