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510(k) K032388

BONE CEMENT RADIO-OPACIFIER by Cardinalhealth — Product Code MYU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2003
Date Received
August 4, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
Device Class
Class II
Regulation Number
882.5300
Review Panel
NE
Submission Type

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Other clearances for product code MYU

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