The following data is part of a premarket notification filed by Lacrimedics, Inc. with the FDA for Opaque Herrick Lacrimal Plug, 0.3mm,0.5mm,0.7mm, Models Hlp3-opb,hlp50opb,hlp7-opb.
| Device ID | K021831 |
| 510k Number | K021831 |
| Device Name: | OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-04 |
| Decision Date | 2002-07-01 |