510(k) K070169

KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE by KLS Martin L.P. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2007
Date Received
January 18, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type