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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
510(k) Number K140761
Device Name KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA
Applicant
Carefusion 2200, Inc.
72 N. Fairway Dr.
Vernon Hills,  IL  60061
Applicant Contact JANE WEBER
Correspondent
Carefusion 2200, Inc.
72 N. Fairway Dr.
Vernon Hills,  IL  60061
Correspondent Contact JANE WEBER
Regulation Number884.1300
Classification Product Code
HES  
Date Received03/26/2014
Decision Date 04/21/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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