Clearance Summary
DEEP BALFOUR BLADE FOR WILKINSON RETRACT received FDA 510(k) clearance under submission number K801611, sponsored by Edward Weck, 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 1980-08-04.
- Submission: K801611
- Applicant / Sponsor: Edward Weck, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1980-08-04
Classification & Regulation
This clearance is catalogued under FDA product code GAD and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.