ClearanceBrief
510(k) K063223 ยท HDW Diaphragm, Contraceptive (And Accessories)

MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS

ApplicantCooperSurgical, Inc., Shelton CT, US
DecisionSubstantially Equivalent, Jan 23, 2008
ReceivedOct 24, 2006
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K063223

DateFirm and productCodeLinked 510(k)
Mar 4, 2016CooperSurgical, Inc.
Milex Arcing Diaphragm Size 95; Model Number: MXWS95
Terminated		 HDWNone listed
Jun 18, 2015CooperSurgical, Inc.
MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80
Terminated		 HDWNone listed
Mar 28, 2013Cooper Surgical, Inc.
Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.
Terminated		 HDWNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.