510(k) K914908

QUICVAGE PLUS by Autovage — Product Code KDH

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
April 13, 1992
Date Received
November 1, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type