510(k) K133795 ยท MAV Syringe, Balloon Inflation
SUMMED INFLATION DEVICE KIT
| Applicant | Sunny Medical Device (Shenzhen) Co., Ltd., Irvine CA, US |
| Decision | Substantially Equivalent, Dec 12, 2014 |
| Received | Dec 13, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133795
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.