510(k) K924485 ยท HET Laparoscope, Gynecologic (And Accessories)
LAPAROSCOPY SET
| Applicant | Owens Precision Systems, Inc., Oak Creek WI, US |
| Decision | Substantially Equivalent, Mar 9, 1994 |
| Received | Sep 3, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K924485
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.