The following data is part of a premarket notification filed by Lacrimedics, Inc. with the FDA for Opaque Herrick Plug, 0.3mm; 0.5mm; O.7mm.
Device ID | K001737 |
510k Number | K001737 |
Device Name: | OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM |
Classification | Plug, Punctum |
Applicant | LACRIMEDICS, INC. 310 PRUNE ALLEY Eastsound, WA 98245 |
Contact | Brian P Logan |
Correspondent | Brian P Logan 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 | 2000-06-07 |
Decision Date | 2000-06-19 |