Clearance Summary
RELIANCE MOD-U-LINE M-700 received FDA 510(k) clearance under submission number K761147, sponsored by F. & F. Koenigkramer. 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 1977-01-28.
- Submission: K761147
- Applicant / Sponsor: F. & F. Koenigkramer
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6910
- Decision date: 1977-01-28
Classification & Regulation
This clearance is catalogued under FDA product code FPO and 21 CFR 880.6910, within the General Hospital review panel as a Class II device.