The following data is part of a premarket notification filed by Rochal Industries, Llc with the FDA for Rochal Antimicrobial Wound Gel.
| Device ID | K192527 |
| 510k Number | K192527 |
| Device Name: | Rochal Antimicrobial Wound Gel |
| Classification | Dressing, Wound, Drug |
| Applicant | Rochal Industries, LLC 12000 Network Blvd, Ste B200 San Antonio, TX 78249 |
| Contact | William J. Coulston |
| Correspondent | William J. Coulston Rochal Industries, LLC 12000 Network Blvd, Ste B200 San Antonio, TX 78249 |
| 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 | 2019-09-13 |
| Decision Date | 2020-02-07 |