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510(k) K040324

WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH by Wilson-Cook Medical, Inc. — Product Code FDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2004
Date Received
February 10, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Cytology Brush
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To collect cells for cytological evaluation.

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