510(k) K091339 ยท LPL Lenses, Soft Contact, Daily Wear
BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
| Applicant | CooperVision, Inc., Norfolk VA, US |
| Decision | Substantially Equivalent, Jan 5, 2010 |
| Received | May 6, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091339
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2013 | CooperVision Inc. ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses for astigmatism, STERILE, Rx only --- CooperVision Hamble, SO31 4RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 Terminated |
MVN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.