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510(k) K062553

SIMPLEX P BONE CEMENT by Stryker Orthopaedics — Product Code LOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2007
Date Received
August 30, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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