The following data is part of a premarket notification filed by Ophthalmic Consultants, Inc. with the FDA for Scleral Plugs, 19 And 20 Gauge.
| Device ID | K990872 |
| 510k Number | K990872 |
| Device Name: | SCLERAL PLUGS, 19 AND 20 GAUGE |
| Classification | Plug, Scleral |
| Applicant | OPHTHALMIC CONSULTANTS, INC. 65 N. MAIN, SUITE 101 PO BOX 154 Tooele, UT 84074 |
| Contact | John E Lincoln |
| Correspondent | John E Lincoln OPHTHALMIC CONSULTANTS, INC. 65 N. MAIN, SUITE 101 PO BOX 154 Tooele, UT 84074 |
| Product Code | LXP |
| CFR Regulation Number | 886.4155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-16 |
| Decision Date | 1999-07-13 |
| Summary: | summary |