K182733 is an FDA 510(k) clearance for the Rochal Bioshield Silicone Film. This device is classified as a Bandage, Liquid (Class I - General Controls, product code KMF).
Submitted by Rochal Industries, LLC (San Antonio, US). The FDA issued a Cleared decision on June 27, 2019, 272 days after receiving the submission on September 28, 2018.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5090.
| 510(k) Number | K182733 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2018 |
| Decision Date | June 27, 2019 |
| Days to Decision | 272 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KMF - Bandage, Liquid |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5090 |