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510(k) K180300

Margolin HSG Cannula, Goldstein Sonohysterography Catheter by Cook Incorporated — Product Code LKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2018
Date Received
February 2, 2018
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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