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510(k) K150158

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2015
Date Received
January 23, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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