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U.S. Department of Health and Human Services

Product Classification

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Device changer, radiographic film/cassette
Regulation Description Radiographic film/cassette changer.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeKPX
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type Enforcement Discretion
Regulation Number 892.1860
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review
Accredited Persons

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