510(k) K112734 ยท FIE Needle, Fistula
APLAN A.V. FISTULA NEEDLE SET
| Applicant | Aplan Well Enterprise Co., Ltd., Hsin Chu City, TW |
| Decision | Substantially Equivalent, Apr 24, 2012 |
| Received | Sep 20, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112734
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.