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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis, partial ossicular replacement
Regulation Description Partial ossicular replacement prosthesis.
Regulation Medical Specialty Ear Nose & Throat
Review Panel Ear Nose & Throat
Product CodeETB
Premarket Review Division of Dental and ENT Devices (DHT1B)
Division of Dental and ENT Devices (DHT1B)
Submission Type 510(k)
Regulation Number 874.3450
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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