The following data is part of a premarket notification filed by Seriously Clean Ltd with the FDA for Nixall Tm Wound And Skin Care.
| Device ID | K113693 |
| 510k Number | K113693 |
| Device Name: | NIXALL TM WOUND AND SKIN CARE |
| Classification | Dressing, Wound, Drug |
| Applicant | SERIOUSLY CLEAN LTD 1075 W. KATHRYN ST. SUITE 6 Nixa, MO 65714 |
| Contact | Kip Glass |
| Correspondent | Kip Glass SERIOUSLY CLEAN LTD 1075 W. KATHRYN ST. SUITE 6 Nixa, MO 65714 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-16 |
| Decision Date | 2012-12-11 |
| Summary: | summary |