510(k) K161623 ยท FRO Dressing, Wound, Drug
Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL
| Applicant | B.Braun Medical, Inc., Allentown PA, US |
| Decision | Substantially Equivalent, Nov 10, 2016 |
| Received | Jun 13, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161623
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.