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FDA 510(k) Application Details - K083594
Device Classification Name
Cannula, Manipulator/Injector, Uterine
More FDA Info for this Device
510(K) Number
K083594
Device Name
Cannula, Manipulator/Injector, Uterine
Applicant
OBG PRODUCTS
8292C OLD COURTHOUSE RD.
VIENNA, VA 22182 US
Other 510(k) Applications for this Company
Contact
AL MUZZAMMEL
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
12/05/2008
Decision Date
07/21/2009
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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