510(k) K872165 ยท FRO Dressing, Wound, Drug
ELASTO-GEL OCCLUSIVE DRESSING
| Applicant | Southwest Technologies, Inc., Kansas City MO, US |
| Decision | Substantially Equivalent for Some Indications, Jun 26, 1987 |
| Received | Jun 5, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K872165
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 13, 2019 | Southwest Technologies Inc Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic Terminated |
FRO | None listed |
| May 4, 2006 | Southwest Technologies Inc Elasto-Gel Wound Dressings, 3 product codes: DR8050, DR 8000, and DR 8000LV (for foreign distribution only), 4'' x 4'', Sterile, each package contains 1 wound dressing, 5 packages per intermediate bo Terminated |
FRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.