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 |