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510(k) K063857

SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT by Howmedica Osteonics Corp. — Product Code MBB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2007
Date Received
December 28, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Cement, Antibiotic
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type

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