Clearance Summary
ADVANCED MEDICAL SOLUTIONS-SILICONE GEL SCAR MANAGEMENT SHEET received FDA 510(k) clearance under submission number K991630, sponsored by Advanced Medical Solutions Group Plc. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1999-06-11.
- Submission: K991630
- Applicant / Sponsor: Advanced Medical Solutions Group Plc
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4025
- Decision date: 1999-06-11
Classification & Regulation
This clearance is catalogued under FDA product code MDA and 21 CFR 878.4025, within the General, Plastic Surgery review panel as a Class I device.