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510(k) K252183

Resitu Slider 09 (RESL09) by Resitu Medical AB — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2025
Date Received
July 11, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
SU
Submission Type

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