Clearance Summary
SKIFA, PLASTIC DISPOSABLE SYRINGE received FDA 510(k) clearance under submission number K883227, sponsored by P.T. Setio Harto , Ltd.. 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 1988-09-29.
- Submission: K883227
- Applicant / Sponsor: P.T. Setio Harto , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 1988-09-29
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.