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U.S. Department of Health and Human Services

Product Classification

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Device detector, ultraviolet
Regulation Description Ultraviolet detector.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeEAQ
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type 510(k)
Regulation Number 872.6350
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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