ClearanceBrief
510(k) K972467 ยท CAF Nebulizer (Direct Patient Interface)

STERILE WATER FOR INHALATION, USP

ApplicantHolopack International, LP, Columbia SC, US
DecisionSubstantially Equivalent, Aug 28, 1997
ReceivedJul 1, 1997
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K972467

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.