Clearance Summary
SURGICAL BURS received FDA 510(k) clearance under submission number K880706, sponsored by Nuell Air Equipment & Hospital Supplies, 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 1988-02-26.
- Submission: K880706
- Applicant / Sponsor: Nuell Air Equipment & Hospital Supplies, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 1988-02-26
Classification & Regulation
This clearance is catalogued under FDA product code GFF and 21 CFR 878.4820, within the General, Plastic Surgery review panel as a Class I device.