510(k) K083355 ยท FRO Dressing, Wound, Drug
WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553
| Applicant | Blairex Laboratories, Inc., Columbus IN, US |
| Decision | Substantially Equivalent, Dec 29, 2008 |
| Received | Nov 13, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083355
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.