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510(k) K201355

Endomat Select, IBS Shaver Software, License by Karl Storz SE & CO. KG — Product Code HIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2020
Date Received
May 21, 2020
Clearance Type
Special
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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