Clearance Summary
BK-7505 RADIOPAQUE GONIOMETER, 8 received FDA 510(k) clearance under submission number K801716, sponsored by Fred Sammons, 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 1980-08-04.
- Submission: K801716
- Applicant / Sponsor: Fred Sammons, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.1520
- Decision date: 1980-08-04
Classification & Regulation
This clearance is catalogued under FDA product code KQW and 21 CFR 888.1520, within the Orthopedic review panel as a Class I device.