Clearance Summary
SUBCUTANEOUS TUNNELING NEEDLES & HANDLES received FDA 510(k) clearance under submission number K854327, sponsored by Concord Laboratories, 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 1985-11-13.
- Submission: K854327
- Applicant / Sponsor: Concord Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4200
- Decision date: 1985-11-13
Classification & Regulation
This clearance is catalogued under FDA product code GCB and 21 CFR 878.4200, within the General, Plastic Surgery review panel as a Class I device.