510(k) K003805 ยท HET Laparoscope, Gynecologic (And Accessories)
GYNECOLOGICAL LAPAROSCOPES
| Applicant | Global Endoscopy, Inc., Schaumburg IL, US |
| Decision | Substantially Equivalent, Jul 22, 2001 |
| Received | Dec 8, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003805
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.