Clearance Summary
DESERET SURGEON'S GLOVE ACCESSORY received FDA 510(k) clearance under submission number K823086, sponsored by Parke-Davis Co.. 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 1983-01-17.
- Submission: K823086
- Applicant / Sponsor: Parke-Davis Co.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 1983-01-17
Classification & Regulation
This clearance is catalogued under FDA product code KGO and 21 CFR 878.4460, within the General, Plastic Surgery review panel as a Class I device.