510(k) K030365 ยท KKX Drape, Surgical, Antimicrobial
DEROYAL DRAPES, STERILE, NON-STERILE
| Applicant | Deroyal Industries, Inc., Powell TN, US |
| Decision | Substantially Equivalent, Apr 29, 2003 |
| Received | Feb 4, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030365
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2004 | Deroyal Surgical -Rose Hill Impervious Stockinette, Large, 12'' X 48'' or 12'' X 54'', Ref #9806-54, #9816-54, and #9978-12; X-Large, 16'' X 48'', Ref #9978-16 Terminated |
KKX | None listed |
| Sep 29, 2004 | Deroyal Surgical -Rose Hill Stockinette, Single Ply Econo Weave, 8 X 72'', Ref #9999-72. Terminated |
KKX | None listed |
| Sep 29, 2004 | Deroyal Surgical -Rose Hill Stockinette, Single Ply, Standard Weave, 8 X 72'' and 10 X 48'', Ref #9508-72, #9510-48, #9510-48, #9510-60 Terminated |
KKX | None listed |
| Sep 29, 2004 | Deroyal Surgical -Rose Hill Stockinette, Double Ply, Standard Weave, 6 X 60'', 6 X 72'', 8 X 48'', 8 X 60'', 8 X 72'', 10 X 48'' Terminated |
KKX | None listed |
| Sep 29, 2004 | Deroyal Surgical -Rose Hill Stockinette, Double Ply, Econo Weave, 6 X 54'', 6 X 60'', 6 X 72'', 8 X 48'', 8 X 72'', Ref #9984-54, #9984-54, #9985-60, #9986-72,
#9987-48, #9988-60, #9988-72 Terminated |
KKX | None listed |
| Sep 29, 2004 | Deroyal Surgical -Rose Hill Stockinette, Double Ply, Econo Weave, EZ Roll, 6 X 60'', 8 X 60'', Ref#9991-60, #9993-60 Terminated |
KKX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.