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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheters, salpingography
510(k) Number K953314
Device Name CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEM
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
MOV  
Date Received07/12/1995
Decision Date 07/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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