Clearance Summary
BUF-FIX received FDA 510(k) clearance under submission number K842728, sponsored by E K Ind., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1984-08-03.
- Submission: K842728
- Applicant / Sponsor: E K Ind., Inc.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.4010
- Decision date: 1984-08-03
Classification & Regulation
This clearance is catalogued under FDA product code IFP and 21 CFR 864.4010, within the Pathology review panel as a Class I device.