ClearanceBrief
510(k) K040085 ยท HIS Condom

PERSONAL WARMING LUBRICANT

ApplicantQualis, Inc., Des Moines IA, US
DecisionSubstantially Equivalent, Apr 20, 2004
ReceivedJan 16, 2004
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K040085

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.