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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Intrauterine Insemination
510(k) Number K932993
Device Name INTRAUTERINE CATHETER AND INTRODUCER
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 Number884.5250
Classification Product Code
MFD  
Date Received06/18/1993
Decision Date 01/06/1995
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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