510(k) K953951

WILSON-COOK TRIPLE LUMEN BALLOON STONE EXTRACTOR by Wilson-Cook Medical, Inc. — Product Code GCA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1995
Date Received
August 22, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type