510(k) K962185 ยท LPL Lenses, Soft Contact, Daily Wear
HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT HYDROPHILIC CONTACT LENS
| Applicant | CooperVision, Inc., Fairport NY, US |
| Decision | Substantially Equivalent, Dec 17, 1996 |
| Received | Jun 6, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962185
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2003 | Coopervision Inc Frequency 55 Toric (methafilcon B), flexible wear contact lenses (tinted). Responsible firms on the label: CooperVision ** Hamble, SO31 4RF, UK ** Scottsville, NY 14546. Terminated |
LPL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.