The following data is part of a premarket notification filed by Alphamed Inc with the FDA for Tear Pool Dissolvable Punctum Plugs.
| Device ID | K190210 |
| 510k Number | K190210 |
| Device Name: | Tear Pool Dissolvable Punctum Plugs |
| Classification | Plug, Punctum |
| Applicant | AlphaMed Inc 3912 Mountain Ave El Paso, TX 79930 |
| Contact | James Gubachy |
| Correspondent | James Gubachy AlphaMed Inc 3912 Mountain Ave El Paso, TX 79930 |
| 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 | 2019-02-04 |
| Decision Date | 2019-10-24 |
| Summary: | summary |