The following data is part of a premarket notification filed by Porex Surgical, Inc. with the FDA for Medpor Coated Tear Drain.
| Device ID | K012108 |
| 510k Number | K012108 |
| Device Name: | MEDPOR COATED TEAR DRAIN |
| Classification | Lacrimal Stents And Intubation Sets |
| Applicant | POREX SURGICAL, INC. 15 DART RD. Newnan, GA 30265 |
| Contact | Howard Mercer |
| Correspondent | Howard Mercer POREX SURGICAL, INC. 15 DART RD. Newnan, GA 30265 |
| Product Code | OKS |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-06 |
| Decision Date | 2001-12-19 |
| Summary: | summary |