510(k) K150151 ยท FYA Gown, Surgical
SmartGownTM surgical gown
| Applicant | Cardinal Health 200, Inc., Waukegan IL, US |
| Decision | Substantially Equivalent, May 21, 2015 |
| Received | Jan 23, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150151
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2021 | Cardinal Health SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line
SKU: 32474 Open, Classified |
FYA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.