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U.S. Department of Health and Human Services

Product Classification
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Device porous polyethylene ossicular replacement
Regulation Description Partial ossicular replacement prosthesis.
Regulation Medical Specialty Ear Nose & Throat
Review Panel Ear Nose & Throat
Product CodeLBM
Submission Type 510(k)
Regulation Number 874.3450
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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