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U.S. Department of Health and Human Services

Product Classification

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Device programmer, changer, film/cassette, radiographic
Regulation Description Radiographic film/cassette changer programmer.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeIZP
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type Enforcement Discretion
Regulation Number 892.1870
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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