510(k) K811632 ยท GDY Gauze/Sponge, Internal, X-Ray Detectable
UNSTERILIZED LAPAROTOMY SPONGES (CHINA)
| Applicant | Robert I. Chien & Assoc., Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 11, 1981 |
| Received | Jun 9, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K811632
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.