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510(k) K212820

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2022
Date Received
September 3, 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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