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FDA 510(k) Application Details - K130758
Device Classification Name
Cannula, Manipulator/Injector, Uterine
More FDA Info for this Device
510(K) Number
K130758
Device Name
Cannula, Manipulator/Injector, Uterine
Applicant
KRONNER PROTOTYPES, INC.
1443 UPPER CLEVELAND RAPIDS RD
ROSEBURG, OR 97471 US
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Contact
RICHARD F KRONNER, M.D.
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LKF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/20/2013
Decision Date
12/11/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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