510(k) K072831

FROG by Newby-Coombs, LLC — Product Code FPD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2008
Date Received
October 3, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Feeding
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type