Clearance Summary
EXTENSION SETS received FDA 510(k) clearance under submission number K864692, sponsored by Salt Creek Medical Technologies. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1986-12-18.
- Submission: K864692
- Applicant / Sponsor: Salt Creek Medical Technologies
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1986-12-18
Classification & Regulation
This clearance is catalogued under FDA product code FPK and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.