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510(k) Premarket Notification Database

Device Classification Name cannula, manipulator/injector, uterine
510(k) NumberK911887
Device NameMAJOLI UTERINE MANIPULATOR/INJECTOR
Applicant
COOK OB/GYN
1100 west morgan st.
p.o. box 271
spencer,  IN  47460
Contactmichelle young
Classification Product Code
LKF
Date Received04/29/1991
Decision Date 07/26/1991
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
Statement/Summary/Purged Status Statement/purged 510(k)
Type Traditional
Reviewed by Third Party No
Expedited Review

Database Updated 03/06/2009

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