510(k) K914907

QUICVAGE by Autovage — Product Code KDH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 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