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FDA 510(k) Application Details - K032835
Device Classification Name
Cannula, Manipulator/Injector, Uterine
More FDA Info for this Device
510(K) Number
K032835
Device Name
Cannula, Manipulator/Injector, Uterine
Applicant
CATHETER RESEARCH, INC.
6131 WEST 80TH ST.
INDIANAPOLIS, IN 46278 US
Other 510(k) Applications for this Company
Contact
JOHN A STEEN
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
09/11/2003
Decision Date
12/11/2003
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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