1249105

DeGen Medical Inc. — FEI 3010663372

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 12, 2024
Fiscal Year
2024
Product Type
Devices
Project Area
Compliance: Devices
Location
Florence, SC (United States)

Citations

IDCFRDescription
319221 CFR 820.30(g)Design validation - user needs and intended uses
319321 CFR 820.30(g)Design validation - simulated testing