510(k) K972109 ยท FZW Expander, Surgical, Skin Graft
SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER
| Applicant | General Surgical Innovations, Cupertino CA, US |
| Decision | Substantially Equivalent, Nov 14, 1997 |
| Received | Jun 5, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972109
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.