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510(k) K981166

ACCUCORE CORE BIOPSY NEEDLE CATALOG CODES:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214 by Inrad — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1998
Date Received
March 31, 1998
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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