510(k) K993720

CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER by Cordis Corp. — Product Code KNQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2000
Date Received
November 3, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Esophageal
Device Class
Class II
Regulation Number
876.5365
Review Panel
GU
Submission Type