510(k) K113759 ยท LPL Lenses, Soft Contact, Daily Wear
AVAIRA (ENFILCON A) CONTACT LENS
| Applicant | CooperVision, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Apr 3, 2012 |
| Received | Dec 21, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113759
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 3, 2013 | Cooper Vision Caribbean Corp. AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses Terminated |
LPL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.