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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diaphragm, Contraceptive (And Accessories)
510(k) Number K063223
Device Name MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS
Applicant
Coopersurgical Inc.,
543 Long Hill Ave.
Shelton,  CT  06484
Applicant Contact JOSEPH AZARY
Correspondent
Coopersurgical Inc.,
543 Long Hill Ave.
Shelton,  CT  06484
Correspondent Contact JOSEPH AZARY
Regulation Number884.5350
Classification Product Code
HDW  
Date Received10/24/2006
Decision Date 01/23/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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