Clearance Summary
PROXIDERM, MODELS TN 460, TN 90 460, BK 460 received FDA 510(k) clearance under submission number K982439, sponsored by Progressive Surgical Products, 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 1998-09-08.
- Submission: K982439
- Applicant / Sponsor: Progressive Surgical Products, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4320
- Decision date: 1998-09-08
Classification & Regulation
This clearance is catalogued under FDA product code MKY and 21 CFR 878.4320, within the General, Plastic Surgery review panel as a Class I device.