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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 K061679
Device Name WALLACE ARTIFICIAL INSEMINATION CATHETER
Applicant
IRVINE SCIENTIFIC SALES CO., INC.
2511 DAIMLER ST.
SANTA ANA,  CA  92705
Applicant Contact WENDELL LEE
Correspondent
IRVINE SCIENTIFIC SALES CO., INC.
2511 DAIMLER ST.
SANTA ANA,  CA  92705
Correspondent Contact WENDELL LEE
Regulation Number884.4530
Classification Product Code
LKF  
Subsequent Product Code
MQF  
Date Received06/15/2006
Decision Date 10/13/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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