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U.S. Department of Health and Human Services

Product Classification

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Device cephalometer
Regulation Description Cephalometer.
Regulation Medical Specialty Dental
Review Panel Radiology
Product CodeEAG
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 872.1830
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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