510(k) K944418 ยท GCJ Laparoscope, General & Plastic Surgery
THE SPACEMAKER AND THE SPACEMAKER II
| Applicant | General Surgical Innovations, Palo Alto CA, US |
| Decision | Substantially Equivalent, Nov 1, 1994 |
| Received | Sep 8, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944418
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.