510(k) K083337 ยท LYY Latex Patient Examination Glove
NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES
| Applicant | Terang Nusa Sdn Bhd, Kota Bharu, Kelantan, MY |
| Decision | Substantially Equivalent, Jan 27, 2009 |
| Received | Nov 12, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083337
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.