Clearance Summary
SENGEWALD CATALOG NUMBER 55 66 01 received FDA 510(k) clearance under submission number K863323, sponsored by Sengewald/USA, 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 1986-10-29.
- Submission: K863323
- Applicant / Sponsor: Sengewald/USA, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4370
- Decision date: 1986-10-29
Classification & Regulation
This clearance is catalogued under FDA product code KKX and 21 CFR 878.4370, within the General, Plastic Surgery review panel as a Class II device.