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510(k) K142164

MANIPULATOR; MANIPULATOR PRO by Gynetech Pty. , Ltd. — Product Code LKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2014
Date Received
August 6, 2014
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

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