Clearance Summary
VENI-SHIELD received FDA 510(k) clearance under submission number K842999, sponsored by U.S. Mfg. & Management, Inc.. 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 1984-09-24.
- Submission: K842999
- Applicant / Sponsor: U.S. Mfg. & Management, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5210
- Decision date: 1984-09-24
Classification & Regulation
This clearance is catalogued under FDA product code KMK and 21 CFR 880.5210, within the General Hospital review panel as a Class I device.