510(k) K860863

ENDO-TRIPTON, MECHANICAL GALLSTONE CRUSHER by George Percy Mcgown — Product Code LQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1986
Date Received
March 7, 1986
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