510(k) K052918

REPROCESSED EXTERNAL FIXATION DEVICES by Alliance Medical Corp. — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2006
Date Received
October 17, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type