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510(k) K011178

WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR by Wilson-Cook Medical, Inc. — Product Code LQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2001
Date Received
April 17, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lithotriptor, Biliary Mechanical
Device Class
Class II
Regulation Number
876.4500
Review Panel
GU
Submission Type

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