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510(k) K180735

Endomat Select by Karl Storz SE & CO. KG — Product Code HIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2018
Date Received
March 22, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Hysteroscopic
Device Class
Class II
Regulation Number
884.1700
Review Panel
OB
Submission Type

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