510(k) K874813 ยท FPX Strip, Adhesive, Closure, Skin
OMED WOUND CLOSURE STRIPS
| Applicant | Oxboro Medical Intl., Inc., Bloomington MN, US |
| Decision | Substantially Equivalent, Jan 29, 1988 |
| Received | Nov 24, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K874813
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 20, 2013 | Aspen Surgical Products, Inc. Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100 mm, (2 Cards/pouch, 1,000 Pouches/box);
Distributed in Europe: " Product N Terminated |
FPX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.