510(k) K011183 ยท GCJ Laparoscope, General & Plastic Surgery
OMNIPORT HAND AND INSTRUMENT ACCESS DEVICE
| Applicant | Advanced Surgical Concepts (Asc), North Attleboro MA, US |
| Decision | Substantially Equivalent, Jun 15, 2001 |
| Received | Apr 18, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011183
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.