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510(k) K111895

ECHOTIP(R) ULTRA FIDUCIAL NEEDLE by Wilson-Cook Medical Inc./Cook Endoscopy — Product Code NEU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2012
Date Received
July 5, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Marker, Radiographic, Implantable
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type

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  • K171607 — Bronchi and Gastrointestinal Cytology Brush (July 31, 2017)
  • K121505 — DISPOSABLE HEMOSTASIS CHIP (August 31, 2012)

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