510(k) K965055 ยท HET Laparoscope, Gynecologic (And Accessories)
IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES
| Applicant | Imagyn Medical, Inc., Laguna Niguel CA, US |
| Decision | Substantially Equivalent, Mar 6, 1997 |
| Received | Dec 18, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965055
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.