510(k) K061308 ยท FYA Gown, Surgical
TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N
| Applicant | Cardinal Health 200, Inc., Waukegan IL, US |
| Decision | Substantially Equivalent, Jun 5, 2006 |
| Received | May 10, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061308
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 24, 2020 | Cardinal Health AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA Terminated |
FYA | None listed |
| Jan 24, 2020 | Cardinal Health AAMI 3 FABREINF SURG GOWN L NS, Item Code 9511NB Terminated |
FYA | None listed |
| Jan 24, 2020 | Cardinal Health AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA Terminated |
FYA | None listed |
| Jan 24, 2020 | Cardinal Health AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB Terminated |
FYA | None listed |
| Jan 24, 2020 | Cardinal Health AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB Terminated |
FYA | None listed |
| Jan 24, 2020 | Cardinal Health AAMI 3 FABRIC REINF SURG GOWN XL NS, Item Code 9541NA Terminated |
FYA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.