The following data is part of a premarket notification filed by Simple Science, Llc with the FDA for Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz.
Device ID | K160095 |
510k Number | K160095 |
Device Name: | Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz |
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 | 2016-01-19 |
Decision Date | 2016-06-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10735282400992 | K160095 | 000 |
10735282400985 | K160095 | 000 |