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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, manual, specialized obstetric-gynecologic
510(k) Number K082939
Device Name COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400
Applicant
COOK UROLOGICAL, INC.
750 DANIELS WAY
BLOOMINGTON,  IN  47404
Applicant Contact CINDY FOOTE
Correspondent
COOK UROLOGICAL, INC.
750 DANIELS WAY
BLOOMINGTON,  IN  47404
Correspondent Contact CINDY FOOTE
Regulation Number884.4530
Classification Product Code
KNA  
Date Received10/02/2008
Decision Date 09/03/2009
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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