510(k) K972832 ยท FYA Gown, Surgical
PROVISION SURGICAL HELMET SYSTEM
| Applicant | Depuy, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Oct 21, 1997 |
| Received | Jul 30, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972832
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2003 | Depuy Orthopaedics, Inc. ProVision Hytrel Elastomer Hood; product 5431-05-000. Terminated |
FYA | None listed |
| Jul 23, 2003 | Depuy Orthopaedics, Inc. ProVision Hytrel Universal Hood/Gown; product 5431-31-000 Terminated |
FYA | None listed |
| Jul 23, 2003 | Depuy Orthopaedics, Inc. ProVision Disposable Hood; product 5431-50-000 Terminated |
FYA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.