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U.S. Department of Health and Human Services

Product Classification
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Device bone cement, antibiotic
Regulation Description Polymethylmethacrylate (PMMA) bone cement.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeMBB
Submission Type 510(k)
Regulation Number 888.3027
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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