510(k) K051477 ยท LPL Lenses, Soft Contact, Daily Wear
MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, TINTED AND COSMETIC)
| Applicant | Mi Gwang Contact Lens Co., Ltd., Grand Junction CO, US |
| Decision | Substantially Equivalent, Mar 10, 2006 |
| Received | Jun 3, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051477
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 26, 2006 | Hebron International, Inc. Soft Cosmetic Contact Lenses sold under the brand names: Circle Lens, Europa, Pacifica, Gothika and Water Color * Manufactured for Softlens Technology, Marietta, GA 30060. Terminated |
LPL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.