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510(k) K212284

Disposable Automatic Core Biopsy Instrument by Suzhou Leapmed Healthcare Corporation — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2021
Date Received
July 21, 2021
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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