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510(k) K223520

UNIDRIVE SIII System by Karl Storz-Endoscopy-America, Inc. — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2023
Date Received
November 23, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hysteroscope (And Accessories)
Device Class
Class II
Regulation Number
884.1690
Review Panel
OB
Submission Type

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