510(k) K953364 ยท HET Laparoscope, Gynecologic (And Accessories)
SPECULITE
| Applicant | Trylon Corp., Monarch Beach CA, US |
| Decision | Substantially Equivalent, Dec 8, 1995 |
| Received | Jul 17, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953364
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.