ClearanceBrief
510(k) K123653 ยท LBH Varnish, Cavity

SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)

ApplicantBisco, Inc., Schaumburg IL, US
DecisionSubstantially Equivalent, Jun 3, 2013
ReceivedNov 27, 2012
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K123653

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.