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510(k) K171596

ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle by Wilson-Cook Medical, Inc. — Product Code FCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2017
Date Received
May 31, 2017
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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