510(k) K912443 ยท FDE Laparoscopy Kit
CANDELA INTRODUCER SHEATH SYSTEM
| Applicant | Candela Laser Corp., Wayland MA, US |
| Decision | Substantially Equivalent, Aug 16, 1991 |
| Received | Jun 3, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912443
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.