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510(k) K081163

SMARTSET GMV GENTAMICIN BONE CEMENT by DePuy Orthopaedics, Inc. — Product Code MBB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2008
Date Received
April 24, 2008
Clearance Type
Special
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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