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510(k) K063223

Device
MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS
Applicant
COOPERSURGICAL, INC.
510(k) number
K063223
Product code
HDW  
Decision
Substantially Equivalent (SESE)
Decision date
2008-01-23
Date received
2006-10-24
Regulation
884.5350
Classification name
Diaphragm, Contraceptive (and Accessories)
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOSEPH AZARY
Address
543 Long Hill Ave. Shelton CT US 06484 06484

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HDW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K140305CAYA CONTOURED DIAPHRAGMKessel Medintim GmbH2014-08-26
K080040ORTHO ALL-FLEX DIAPHRAGMJohnson & Johnson Produtos Profissionais Ltda.2008-08-25
K800162ONCE TMG.D. Searle and Co.1980-02-11

Legacy Summary#

summary

FDA Review#

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