510(k) K896568

DUALYSE-CATH - CODES #1132.212, 1132.112 by Vygon Corp. — Product Code LFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1990
Date Received
November 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Subclavian
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type