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 |