The following data is part of a premarket notification filed by Microvision, Inc. with the FDA for Scleral Plugs, 19 And 20 Gauge.
| Device ID | K022186 |
| 510k Number | K022186 |
| Device Name: | SCLERAL PLUGS, 19 AND 20 GAUGE |
| Classification | Plug, Scleral |
| Applicant | MICROVISION, INC. 34 FOLLY MILL RD. SUITE 200 P.O. BOX 1651 Seabrook, NH 03874 -1651 |
| Contact | Leonard Kastrilevich |
| Correspondent | Leonard Kastrilevich MICROVISION, INC. 34 FOLLY MILL RD. SUITE 200 P.O. BOX 1651 Seabrook, NH 03874 -1651 |
| Product Code | LXP |
| CFR Regulation Number | 886.4155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-05 |
| Decision Date | 2003-02-26 |
| Summary: | summary |