Clearance Summary
PROCEL(TM) DERMALINER GLOVE received FDA 510(k) clearance under submission number K931094, sponsored by W. L. Gore & Associates, 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 1994-02-14.
- Submission: K931094
- Applicant / Sponsor: W. L. Gore & Associates, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4040
- Decision date: 1994-02-14
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.