510(k) DEN150010
DEN150010 is an FDA 510(k) premarket notification submitted by Dignitana AB for the device "Dignitana AB DigniCap System". The FDA issued a decision of De Novo Granted on December 8, 2015. The device falls under product code PMC (Scalp Cooling System), a Class II device regulated under 21 CFR 878.4360. Dignitana AB has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- December 8, 2015
- Date Received
- March 6, 2015
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scalp Cooling System
- Device Class
- Class II
- Regulation Number
- 878.4360
- Review Panel
- SU
- Submission Type
A scalp cooling system is intended to reduce or prevent the frequency and severity of alopecia during chemotherapy in which alopecia-inducing chemotherapeutic agents are used.