510(k) K964937

A LITHOTRIPTER-COMPATIBLE BASKET by Boston Scientific Corp — Product Code LQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1997
Date Received
December 10, 1996
Clearance Type
Traditional
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