ClearanceBrief
510(k) K172987 ยท FYA Gown, Surgical

Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001)

ApplicantGmax Industries, Inc., Hauppauge NY, US
DecisionSubstantially Equivalent, Jul 13, 2018
ReceivedSep 27, 2017
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K172987

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.