510(k) K943662 ยท HET Laparoscope, Gynecologic (And Accessories)
LAPARASCOPE
| Applicant | Pollux Endoscopy, Inc., Sunrise FL, US |
| Decision | Substantially Equivalent, May 25, 1995 |
| Received | Jul 28, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943662
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.