510(k) K131023

THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN by Medical Products, LLC — Product Code NFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2013
Date Received
April 12, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conserver, Oxygen
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type