DigniCap Delta
Scalp Cooling System
Dignitana Inc.
The following data is part of a premarket notification filed by Dignitana Inc. with the FDA for Dignicap Delta.
Pre-market Notification Details
| Device ID | K191166 |
| 510k Number | K191166 |
| Device Name: | DigniCap Delta |
| Classification | Scalp Cooling System |
| Applicant | Dignitana Inc. 10925 Estate Lane, Suite W-185 Dallas, TX 75238 |
| Contact | William Cronin |
| Correspondent | Valerie Defiesta-ng Experien Group 224 Airport Parkway, Suite 250 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 | 2019-05-01 |
| Decision Date | 2019-06-26 |
Trademark Results [DigniCap Delta]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DIGNICAP DELTA 88218420 5794042 Live/Registered |
Dignitana AB 2018-12-05 |
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