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Dignitana, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0825-2022Class IIDigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The DigniCap Scalp CoolingNovember 5, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K191166DigniCap DeltaJune 26, 2019
K170871DigniCap Scalp Cooling SystemJuly 3, 2017
DEN150010Dignitana AB DigniCap SystemDecember 8, 2015