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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 K140305
Device Name CAYA CONTOURED DIAPHRAGM
Applicant
Kessel Medintim GmbH
Kelsterbacher St. 28
Moerfelden Walldorf
Frankfurt,  DE 64546
Applicant Contact KESSEL MARKETING
Correspondent
Kessel Medintim GmbH
Kelsterbacher St. 28
Moerfelden Walldorf
Frankfurt,  DE 64546
Correspondent Contact KESSEL MARKETING
Regulation Number884.5350
Classification Product Code
HDW  
Date Received02/07/2014
Decision Date 08/26/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Clinical Trials NCT00561613
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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