Clearance Summary
CASF DRILL GUIDE DG 170 received FDA 510(k) clearance under submission number K882871, sponsored by Terray Manufacturing, 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 1988-09-23.
- Submission: K882871
- Applicant / Sponsor: Terray Manufacturing, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 1988-09-23
Classification & Regulation
This clearance is catalogued under FDA product code LYQ and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.