Clearance Summary
AUTOMATIC SHUT-OFF VALVE received FDA 510(k) clearance under submission number K760895, sponsored by Delta Medical Industries. 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 1976-12-09.
- Submission: K760895
- Applicant / Sponsor: Delta Medical Industries
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5420
- Decision date: 1976-12-09
Classification & Regulation
This clearance is catalogued under FDA product code KZD and 21 CFR 880.5420, within the General Hospital review panel as a Class I device.