The following data is part of a premarket notification filed by Lacrimedics, Inc. with the FDA for Opaque Herrick Lacrimal Plug.
| Device ID | K030300 |
| 510k Number | K030300 |
| Device Name: | OPAQUE HERRICK LACRIMAL PLUG |
| Classification | Plug, Punctum |
| Applicant | LACRIMEDICS, INC. 310 PRUNE ALLEY Eastsound, WA 98245 |
| Contact | Jerry Henderson |
| Correspondent | Jerry Henderson LACRIMEDICS, INC. 310 PRUNE ALLEY Eastsound, WA 98245 |
| 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 | 2003-01-29 |
| Decision Date | 2003-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856611008016 | K030300 | 000 |
| 00856611008009 | K030300 | 000 |