510(k) K061948 ยท MVN Lens, Contact, (Disposable)
PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS
| Applicant | CooperVision, Inc., Norfolk VA, US |
| Decision | Substantially Equivalent, Nov 22, 2006 |
| Received | Jul 10, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061948
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2013 | CooperVision Inc. Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx ONLY --- Coopervision Shamble, SO 31 4 RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA
daily us Terminated |
MVN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.