510(k) K943347

KLS MINI OSTEOSYNTHESIS SYSTEM by Patton, Boggs & Blow — Product Code JEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1994
Date Received
July 12, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Bone
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type