Clearance Summary
OMED SILICONE LOOPS received FDA 510(k) clearance under submission number K810260, sponsored by Omega-Med Intl., 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 1981-02-26.
- Submission: K810260
- Applicant / Sponsor: Omega-Med Intl., Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1981-02-26
Classification & Regulation
This clearance is catalogued under FDA product code KDC and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.