510(k) K911895 ยท MDM Instrument, Manual, Surgical, General Use
QUALTEX SUTURE BOOTIES
| Applicant | Deroyal Industries, Inc., Powell TN, US |
| Decision | Substantially Equivalent, May 8, 1991 |
| Received | Apr 29, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911895
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.