510(k) K904779

BUTTON REPLACEMENT GASTROSTOMY DEVICE by C.R. Bard, Inc. — Product Code KGC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1991
Date Received
October 22, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Gastro-Enterostomy
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type