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U.S. Department of Health and Human Services

Product Classification
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Device prosthesis, otoplasty
Regulation Description Ear prosthesis.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeESY
Submission Type 510(k)
Regulation Number 878.3590
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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