Clearance Summary
TU STOPCOCK received FDA 510(k) clearance under submission number K881805, sponsored by Tulan Corp. C/O Richard Hamer Assoc.. 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 1988-10-04.
- Submission: K881805
- Applicant / Sponsor: Tulan Corp. C/O Richard Hamer Assoc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1988-10-04
Classification & Regulation
This clearance is catalogued under FDA product code FMG and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.