510(k) K161950 ยท FMI Needle, Hypodermic, Single Lumen
Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle
| Applicant | Promisemed Hangzhou Meditech Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, May 11, 2017 |
| Received | Jul 15, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161950
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.