Clearance Summary
SILASTIC BRAND PENILE IMPLANT received FDA 510(k) clearance under submission number K780484, sponsored by Dow Corning Corp. Healthcare Industries Materials. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1978-07-17.
- Submission: K780484
- Applicant / Sponsor: Dow Corning Corp. Healthcare Industries Materials
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 1978-07-17
Classification & Regulation
This clearance is catalogued under FDA product code FIQ and 21 CFR 876.5540, within the Gastroenterology, Urology review panel as a Class II device.