The following data is part of a premarket notification filed by Simple Science, Llc with the FDA for Cleansmart Wound Cleanser.
| Device ID | K142592 |
| 510k Number | K142592 |
| Device Name: | CleanSmart Wound Cleanser |
| Classification | Dressing, Wound, Drug |
| Applicant | SIMPLE SCIENCE, LLC 530 NORTH 3RD STREET SUITE 310 Minneapolis, MN 55401 |
| Contact | Justin Scanlan |
| Correspondent | Eoin Croke Simple Science, LLC 5555 W 78th St STE M Edina, MN 55439 |
| 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 | 2014-09-15 |
| Decision Date | 2015-09-02 |
| Summary: | summary |