The following data is part of a premarket notification filed by Rochal Industries Llc with the FDA for Atteris Antimicrobial Skin & Wound Cleanser.
| Device ID | K160192 |
| 510k Number | K160192 |
| Device Name: | Atteris Antimicrobial Skin & Wound Cleanser |
| Classification | Dressing, Wound, Drug |
| Applicant | ROCHAL INDUSTRIES LLC 12719 CRANES MILL San Antonio, TX 78230 |
| Contact | William J. Coulston |
| Correspondent | William J. Coulston ROCHAL INDUSTRIES LLC 12719 CRANES MILL San Antonio, TX 78230 |
| 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 | 2016-01-27 |
| Decision Date | 2016-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20860000939557 | K160192 | 000 |
| 00860000939539 | K160192 | 000 |