Clearance Summary
PARADERM(TM) SURGEON'S GLOVE ACCESSORY received FDA 510(k) clearance under submission number K904903, sponsored by Lovell-Schenck, 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 1991-01-08.
- Submission: K904903
- Applicant / Sponsor: Lovell-Schenck, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4040
- Decision date: 1991-01-08
Classification & Regulation
This clearance is catalogued under FDA product code LYU and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class I device.