510(k) K073684 ยท KMJ Lubricant, Patient
SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL
| Applicant | Sheffield Industries, Div. of Faria , Ltd., New London CT, US |
| Decision | Substantially Equivalent, May 22, 2008 |
| Received | Dec 28, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073684
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2015 | Sheffield Pharmaceuticals, LLC Dr. Sheffield's LUBRI GEL 3 oz (85 g)
Non sterile over-the-counter personal lubricant. Terminated |
MMS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.