510(k) K972647 ยท HET Laparoscope, Gynecologic (And Accessories)
CO2 PNEUMO-DISSECTOR
| Applicant | Cook Urological, Inc., Spencer IN, US |
| Decision | Substantially Equivalent, Apr 10, 1998 |
| Received | Jul 15, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972647
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.