The following data is part of a premarket notification filed by Century Pharmaceuticals, Inc. with the FDA for Dakin's Skin And Wound Cleanser.
| Device ID | K150208 |
| 510k Number | K150208 |
| Device Name: | Dakin's Skin And Wound Cleanser |
| Classification | Dressing, Wound, Drug |
| Applicant | CENTURY PHARMACEUTICALS, INC. 10377 HAGUE RD. Indianapolis, IN 46256 |
| Contact | Stephen Deardorff |
| Correspondent | Stephen Deardorff CENTURY PHARMACEUTICALS, INC. 10377 HAGUE RD. Indianapolis, IN 46256 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2015-01-30 |
| Decision Date | 2016-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00304365301612 | K150208 | 000 |
| 00304365300820 | K150208 | 000 |