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510(k) K201970

Schoelly Cystoscopes/Hysteroscopes and Accessories by Schoelly Fiberoptic GmbH — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2020
Date Received
July 15, 2020
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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