510(k) K864669

AM CATH ESWL STENT by Inter-Med Corp. — Product Code FAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1987
Date Received
December 2, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stent, Ureteral
Device Class
Class II
Regulation Number
876.4620
Review Panel
GU
Submission Type