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510(k) K050492

INTEGRA BONE FIXATION SYSTEM by Integra Lifesciences Corp. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2005
Date Received
February 28, 2005
Clearance Type
Special
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

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