Clearance Summary
PROGUARD II(TM) received FDA 510(k) clearance under submission number K896086, sponsored by Safety-Ject, 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 1990-01-24.
- Submission: K896086
- Applicant / Sponsor: Safety-Ject, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 1990-01-24
Classification & Regulation
This clearance is catalogued under FDA product code FMF and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.