1023579

Surgitech Inc — FEI 3004014634

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
August 23, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Carlsbad, CA (United States)

Citations

IDCFRDescription
1471221 CFR 820.184DHR - not or inadequately maintained
243121 CFR 820.30(b)Design plans- updated
263021 CFR 820.30(e)Design review - documentation