510(k) K042066

KLSA MARTIN HAND DISTRACTOR by KLS-Martin L.P. — Product Code JEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2004
Date Received
August 2, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Component, Traction, Invasive
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type