510(k) K051436 ยท PEB Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
PRE' VAGINAL LUBRICANT
| Applicant | Ingfertlity, LLC, Valleyford WA, US |
| Decision | Substantially Equivalent, Oct 13, 2006 |
| Received | Jun 1, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051436
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 23, 2009 | INGfertility, LLC Pre Isotonic Personal Lubricant labeled PRE' Patient Lubricant.
Product is used to lubricate vulvar and vaginal tissues to facilitate entry of diagnostic or therapeutic devices. Pre' Lubricant is acc Terminated |
NUC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.