Clearance Summary
QCR SYSTEM I AND QCR SYSTEM II received FDA 510(k) clearance under submission number K893380, sponsored by Bremer Mfg. & Tool Co., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1989-11-16.
- Submission: K893380
- Applicant / Sponsor: Bremer Mfg. & Tool Co., Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.5960
- Decision date: 1989-11-16
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.