510(k) K932115

ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI by Blairden Precision Instruments, Inc. — Product Code LKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1994
Date Received
May 3, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Manipulator/Injector, Uterine
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type