The following data is part of a premarket notification filed by Dignitana Ab with the FDA for Dignicap Scalp Cooling System.
| Device ID | K170871 |
| 510k Number | K170871 |
| Device Name: | DigniCap Scalp Cooling System |
| Classification | Scalp Cooling System |
| Applicant | Dignitana AB Traktorgranden 3 Lund, SE Se-226 60 |
| Contact | Johan Ericsson |
| Correspondent | Michael J. Billig Experien Group, LLC 224 Airport Parkway San Jose, CA 95110 |
| Product Code | PMC |
| CFR Regulation Number | 878.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-23 |
| Decision Date | 2017-07-03 |
| Summary: | summary |