510(k) K953377 ยท GCJ Laparoscope, General & Plastic Surgery
DISTENTION BALLOON
| Applicant | Origin Medsystems, Inc., Menlo Park CA, US |
| Decision | Substantially Equivalent, Oct 23, 1995 |
| Received | Jul 19, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953377
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.