Clearance Summary
POS-T-VAC ID-300 received FDA 510(k) clearance under submission number K961309, sponsored by Pos-T-Vac, 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 1996-06-10.
- Submission: K961309
- Applicant / Sponsor: Pos-T-Vac, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6920
- Decision date: 1996-06-10
Classification & Regulation
This clearance is catalogued under FDA product code KZH and 21 CFR 880.6920, within the General Hospital review panel as a Class II device.