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510(k) K131264

KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS by Gebr. Brasseler GmbH & Co. KG — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2013
Date Received
May 3, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Gebr. Brasseler GmbH & Co. KG

  • K071352 — CERADRILL (June 29, 2007)

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