Clearance Summary
FORTUNA DISPOSABLE SYRINGES received FDA 510(k) clearance under submission number K851519, sponsored by Impor-Tex, Intl., 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 1985-06-17.
- Submission: K851519
- Applicant / Sponsor: Impor-Tex, Intl., Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 1985-06-17
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.