Clearance Summary
GUILLOTINE BLADE received FDA 510(k) clearance under submission number K831772, sponsored by Ortho Pared Instruments, 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 1983-07-07.
- Submission: K831772
- Applicant / Sponsor: Ortho Pared Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1983-07-07
Classification & Regulation
This clearance is catalogued under FDA product code HTZ and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.