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510(k) K181756

Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle by Apriomed AB — Product Code FCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2018
Date Received
July 2, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biopsy Needle
Device Class
Class II
Regulation Number
876.1075
Review Panel
GU
Submission Type

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