Clearance Summary
SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE received FDA 510(k) clearance under submission number K861711, sponsored by Busse Hospital Disposables, 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 1986-05-16.
- Submission: K861711
- Applicant / Sponsor: Busse Hospital Disposables, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4760
- Decision date: 1986-05-16
Classification & Regulation
This clearance is catalogued under FDA product code GDT and 21 CFR 878.4760, within the General, Plastic Surgery review panel as a Class I device.