Clearance Summary
MODULAR EXTREMITY CASTING SUPPORT received FDA 510(k) clearance under submission number K834384, sponsored by Buckman 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 1984-01-30.
- Submission: K834384
- Applicant / Sponsor: Buckman Co., Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.5980
- Decision date: 1984-01-30
Classification & Regulation
This clearance is catalogued under FDA product code LGG and 21 CFR 888.5980, within the Orthopedic review panel as a Class I device.