The following data is part of a premarket notification filed by Partners In Biomaterials, Inc. with the FDA for Hydrogel Canalicular Plug.
| Device ID | K040912 |
| 510k Number | K040912 |
| Device Name: | HYDROGEL CANALICULAR PLUG |
| Classification | Plug, Punctum |
| Applicant | PARTNERS IN BIOMATERIALS, INC. 466 WEST ARROW HWY., UNIT H San Dimas, CA 91773 |
| Contact | James Christensen |
| Correspondent | James Christensen PARTNERS IN BIOMATERIALS, INC. 466 WEST ARROW HWY., UNIT H San Dimas, CA 91773 |
| 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 | 2004-04-08 |
| Decision Date | 2004-11-16 |
| Summary: | summary |