510(k) K140607

AAP LOQTEC(R) OLECRANON PLATE by Aap Implantate AG — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2014
Date Received
March 10, 2014
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