510(k) K973046 ยท GCJ Laparoscope, General & Plastic Surgery
SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAK
| Applicant | General Surgical Innovations, Cupertino CA, US |
| Decision | Substantially Equivalent, Jan 16, 1998 |
| Received | Aug 15, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973046
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.