510(k) K970312 ยท LPL Lenses, Soft Contact, Daily Wear
CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A)
| Applicant | Flexlens, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, Apr 2, 1997 |
| Received | Jan 27, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970312
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.