The following data is part of a premarket notification filed by Fci Ophthalmics, Inc. with the FDA for Snug Plug Punctum Plug.
Device ID | K061398 |
510k Number | K061398 |
Device Name: | SNUG PLUG PUNCTUM PLUG |
Classification | Plug, Punctum |
Applicant | FCI OPHTHALMICS, INC. 344 ANNABELLE POINT RD. Centerville, MA 02632 -2402 |
Contact | Hillard W Welch |
Correspondent | Hillard W Welch FCI OPHTHALMICS, INC. 344 ANNABELLE POINT RD. Centerville, MA 02632 -2402 |
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 | 2006-05-19 |
Decision Date | 2006-07-11 |