Clearance Summary
SURGICAL PRODUCTS, SKIN STAPLE REMOVER received FDA 510(k) clearance under submission number K822963, sponsored by Temp-Stik Corp.. 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 1982-11-08.
- Submission: K822963
- Applicant / Sponsor: Temp-Stik Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4320
- Decision date: 1982-11-08
Classification & Regulation
This clearance is catalogued under FDA product code FZQ and 21 CFR 878.4320, within the General, Plastic Surgery review panel as a Class I device.