510(k) K003608 ยท HGI Electrocautery, Gynecologic (And Accessories)
SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY
| Applicant | Aesculap, Inc., Allentown PA, US |
| Decision | Substantially Equivalent, Feb 20, 2001 |
| Received | Nov 22, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003608
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.