The following data is part of a premarket notification filed by Lacrimedics, Inc. with the FDA for Lacripro Punctum Plug.
Device ID | K161673 |
510k Number | K161673 |
Device Name: | LacriPro Punctum Plug |
Classification | Plug, Punctum |
Applicant | LACRIMEDICS, INC. 2620 WILLIAMSON PLACE NW, SUITE 113 Dupont, WA 98245 |
Contact | Rebecca C. Dutton |
Correspondent | Rebecca C. Dutton LACRIMEDICS, INC. 2620 WILLIAMSON PLACE NW, SUITE 113 Dupont, 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 | 2016-06-16 |
Decision Date | 2016-11-18 |
Summary: | summary |