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510(k) K000612

ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE by Inrad — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2000
Date Received
February 23, 2000
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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