510(k) K946002 ยท GEX Powered Laser Surgical Instrument
ORIGIN PREPERITONEAL DISSECTION BALLOON SYSTEM (PDBS)--EXTRA
| Applicant | Origin Medsystems, Inc., Menlo Park CA, US |
| Decision | Substantially Equivalent, Jan 5, 1995 |
| Received | Nov 22, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946002
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.