510(k) K073718

MEDLINE GASTROSTOMY TUBE by Medline Industries, Inc. — Product Code KGC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2008
Date Received
December 31, 2007
Clearance Type
Abbreviated
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