510(k) K971255 ยท HET Laparoscope, Gynecologic (And Accessories)
IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER
| Applicant | Imagyn Medical, Inc., Laguna Niguel CA, US |
| Decision | Substantially Equivalent, Apr 21, 1997 |
| Received | Apr 4, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971255
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.