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U.S. Department of Health and Human Services

Product Classification

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Device cone, radiographic
Regulation Description Diagnostic x-ray beam-limiting device.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeIZT
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type Enforcement Discretion
Regulation Number 892.1610
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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