The following data is part of a premarket notification filed by Rochal Industries, Llc with the FDA for Rochal Bioshield Silicone Film.
| Device ID | K182733 |
| 510k Number | K182733 |
| Device Name: | Rochal Bioshield Silicone Film |
| Classification | Bandage, Liquid |
| 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 | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-28 |
| Decision Date | 2019-06-27 |