510(k) K070988 ยท FMI Needle, Hypodermic, Single Lumen
SC PROFI FINE PEN NEEDLE, MODELS; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G)
| Applicant | Shinchang Medical Co., Ltd., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Aug 23, 2007 |
| Received | Apr 6, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070988
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.