The following data is part of a premarket notification filed by U.s. Iol, Inc. with the FDA for Occu-flo Punctum Plugs.
Device ID | K001768 |
510k Number | K001768 |
Device Name: | OCCU-FLO PUNCTUM PLUGS |
Classification | Plug, Punctum |
Applicant | U.S. IOL, INC. 2500 SANDERSVILLE RD. Lexington, KY 40511 |
Contact | Teresa Burton |
Correspondent | Teresa Burton U.S. IOL, INC. 2500 SANDERSVILLE RD. Lexington, KY 40511 |
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 | 2000-06-12 |
Decision Date | 2000-09-19 |