Clearance Summary
SURGICAL BLADE HANDLES received FDA 510(k) clearance under submission number K761035, 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 1976-12-21.
- Submission: K761035
- Applicant / Sponsor: Parke-Davis Co.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1976-12-21
Classification & Regulation
This clearance is catalogued under FDA product code GDZ and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.