The following data is part of a premarket notification filed by Lacrimedics, Inc. with the FDA for Collasyn Plug For The Lacrimal Efficiency Test.
| Device ID | K140026 |
| 510k Number | K140026 |
| Device Name: | COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST |
| Classification | Plug, Punctum |
| Applicant | LACRIMEDICS, INC. 2620 Williamson Pl NW Ste 113 Du Pont, WA 98327 |
| Contact | Rebecca Dutton |
| Correspondent | Rebecca Dutton LACRIMEDICS, INC. 2620 Williamson Pl NW Ste 113 Du Pont, WA 98327 |
| Product Code | LZU |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-06 |
| Decision Date | 2014-06-03 |
| Summary: | summary |