510(k) K052062

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2005
Date Received
July 29, 2005
Clearance Type
Special
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