ClearanceBrief
510(k) K004016 ยท HIS Condom

SHEER THIN AROMAS BLUE LATEX CONDOM

ApplicantEagle Twe, Inc., Tucker GA, US
DecisionSubstantially Equivalent, Mar 27, 2001
ReceivedDec 27, 2000
TypeAbbreviated
FDA recordOpen on fda.gov

Recalls that name K004016

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.