Clearance Summary
NEARLY ME RETOUCH SILICONE SCAR REDUCTION SHEETS received FDA 510(k) clearance under submission number K984213, sponsored by Capital Marketing Technologies, Inc.. 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 1999-04-14.
- Submission: K984213
- Applicant / Sponsor: Capital Marketing Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4025
- Decision date: 1999-04-14
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.