510(k) K132314

MEDLINE ANTI-REFLUX VALVE by Medline Industries, Inc. — Product Code FEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2013
Date Received
July 25, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Double Lumen For Intestinal Decompression And/Or Intubation
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type