Clearance Summary
Rochal Bioshield Silicone Film received FDA 510(k) clearance under submission number K182733, sponsored by Rochal Industries, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2019-06-27.
- Submission: K182733
- Applicant / Sponsor: Rochal Industries, LLC
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5090
- Decision date: 2019-06-27
Classification & Regulation
This clearance is catalogued under FDA product code KMF and 21 CFR 880.5090, within the General Hospital review panel as a Class I device.