510(k) K944200 ยท HET Laparoscope, Gynecologic (And Accessories)
HI-Q HAND INSTRUMENTS, OB/GYN USE
| Applicant | Olympus America, Inc., Lake Success NY, US |
| Decision | Substantially Equivalent, Sep 15, 1995 |
| Received | Aug 29, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944200
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.