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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Manipulator/Injector, Uterine
510(k) Number K933981
Device Name CERVICAL CATHETER
Applicant
Conceptus, Inc.
1021 Howard Ave.
San Carlos,  CA  94070
Applicant Contact ALEXIS BALL
Correspondent
Conceptus, Inc.
1021 Howard Ave.
San Carlos,  CA  94070
Correspondent Contact ALEXIS BALL
Regulation Number884.4530
Classification Product Code
LKF  
Date Received08/16/1993
Decision Date 12/27/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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