ClearanceBrief
510(k) K150828 ยท HIS Condom

O-RING Condom

ApplicantO-Ring Products, LLC, Raleigh NC, US
DecisionSubstantially Equivalent, Dec 18, 2015
ReceivedMar 30, 2015
TypeAbbreviated
FDA recordOpen on fda.gov

Recalls that name K150828

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.