510(k) K971896 ยท HET Laparoscope, Gynecologic (And Accessories)
GALILEO HIGH RESOLUTION MICRO COUPLER
| Applicant | Netoptix Corp., Sturbridge MA, US |
| Decision | Substantially Equivalent, Oct 10, 1997 |
| Received | May 22, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971896
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.