Clearance Summary
DISPO. AES DISPOS. SYRINGE W/NEEDLE received FDA 510(k) clearance under submission number K841931, sponsored by Hirsch Chemie , 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 1984-07-06.
- Submission: K841931
- Applicant / Sponsor: Hirsch Chemie , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 1984-07-06
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.