510(k) K971797 ยท HET Laparoscope, Gynecologic (And Accessories)
LAPAROSCOPIC BLADDER NECK SUSPENSION KIT
| Applicant | Louisville Laboratories, Inc., North Attleboro MA, US |
| Decision | Substantially Equivalent, Jul 22, 1997 |
| Received | May 15, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971797
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.