The following data is part of a premarket notification filed by Simple Science Llc with the FDA for Simple Science Antimicrobial Facial And Eyelid Cleanser.
Device ID | K181074 |
510k Number | K181074 |
Device Name: | Simple Science Antimicrobial Facial And Eyelid Cleanser |
Classification | Dressing, Wound, Drug |
Applicant | Simple Science LLC 5555 W 78th St. STE M Edina, MN 55439 |
Contact | Eoin Croke |
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 | 2018-04-24 |
Decision Date | 2018-08-17 |
Summary: | summary |