The following data is part of a premarket notification filed by Sensor Medical Technology, Llc with the FDA for Family Of Disposable Lenses.
| Device ID | K140368 |
| 510k Number | K140368 |
| Device Name: | FAMILY OF DISPOSABLE LENSES |
| Classification | Prism, Gonioscopic |
| Applicant | SENSOR MEDICAL TECHNOLOGY, LLC 5 TIMBER LANE North Reading, MA 01864 |
| Contact | Maureen O'connell |
| Correspondent | Maureen O'connell SENSOR MEDICAL TECHNOLOGY, LLC 5 TIMBER LANE North Reading, MA 01864 |
| Product Code | HKS |
| CFR Regulation Number | 886.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-14 |
| Decision Date | 2014-04-29 |
| Summary: | summary |