510(k) K954174 ยท GCJ Laparoscope, General & Plastic Surgery
DUO BALLOON SYSTEM (DBS) 2 [10 AND 12 MM SIZES]
| Applicant | Origin Medsystems, Inc., Menlo Park CA, US |
| Decision | Substantially Equivalent, Nov 9, 1995 |
| Received | Sep 5, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954174
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.