FDA 510(k) Applications for Medical Device Product Code "HDW"
(Diaphragm, Contraceptive (And Accessories))

FDA 510(k) Number Applicant Device Name Decision Date
K063223 COOPERSURGICAL, INC. MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS 01/23/2008
K080040 JOHNSON & JOHNSON PRODUTOS PROFISSIONAIS LTDA. ORTHO ALL-FLEX DIAPHRAGM 08/25/2008
K140305 KESSEL MEDINTIM GMBH CAYA CONTOURED DIAPHRAGM 08/26/2014


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