510(k) K171939 ยท GCJ Laparoscope, General & Plastic Surgery
ALVUE Balloon Dilation System
| Applicant | Globus Medical, Inc., Audubon PA, US |
| Decision | Substantially Equivalent, Mar 7, 2018 |
| Received | Jun 28, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171939
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.