510(k) K864529 ยท GDY Gauze/Sponge, Internal, X-Ray Detectable
LAPORATOMY SPONGES SIZES:18X18,12X12,4X18,8X36
| Applicant | Elof Hansson, Inc., Norwalk CT, US |
| Decision | Substantially Equivalent, Dec 16, 1986 |
| Received | Nov 17, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864529
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.