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510(k) K093399

PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520 by Inrad — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2009
Date Received
November 2, 2009
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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