ClearanceBrief
510(k) K092232 ยท FRO Dressing, Wound, Drug

MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014

ApplicantPuricore, Inc., Malvern PA, US
DecisionSubstantially Equivalent, Aug 19, 2009
ReceivedJul 23, 2009
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K092232

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.