Clearance Summary
PLASTER VACUUM, 230V MODEL NO. 4183-161 received FDA 510(k) clearance under submission number K873723, sponsored by Martin Medical. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1987-12-10.
- Submission: K873723
- Applicant / Sponsor: Martin Medical
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.5960
- Decision date: 1987-12-10
Classification & Regulation
This clearance is catalogued under FDA product code LGH and 21 CFR 888.5960, within the Orthopedic review panel as a Class I device.