The following data is part of a premarket notification filed by Lacrimedics, Inc. with the FDA for Lacrimal Efficiency Test (tm).
| Device ID | K890714 |
| 510k Number | K890714 |
| Device Name: | LACRIMAL EFFICIENCY TEST (TM) |
| Classification | Plug, Punctum |
| Applicant | LACRIMEDICS, INC. 9008 NEWBY ST. Rosemead, CA 91770 |
| Contact | Paul G Zickefoose |
| Correspondent | Paul G Zickefoose LACRIMEDICS, INC. 9008 NEWBY ST. Rosemead, CA 91770 |
| 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 | 1989-02-13 |
| Decision Date | 1989-05-17 |