510(k) K964450 ยท HET Laparoscope, Gynecologic (And Accessories)
SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT
| Applicant | Pilling Weck Group, Jeffrey NH, US |
| Decision | Substantially Equivalent, Jan 10, 1997 |
| Received | Nov 6, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964450
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.