510(k) K946359 ยท HET Laparoscope, Gynecologic (And Accessories)
KARL STORZ DILATION SET, REDUCERS, THREAD SLEEVES, DISTANCE HOLDERS
| Applicant | KARL STORZ Endoscopy-America, Inc., Culver City CA, US |
| Decision | Substantially Equivalent, May 11, 1995 |
| Received | Dec 30, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946359
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.