Clearance Summary
HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001 received FDA 510(k) clearance under submission number K021916, sponsored by Harmac Medical Products, 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 2002-08-29.
- Submission: K021916
- Applicant / Sponsor: Harmac Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2002-08-29
Classification & Regulation
This clearance is catalogued under FDA product code FPA and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.