Clearance Summary
HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET) received FDA 510(k) clearance under submission number K101547, sponsored by Henke-Sass, Wolf GmbH. 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 2010-11-22.
- Submission: K101547
- Applicant / Sponsor: Henke-Sass, Wolf GmbH
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2010-11-22
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.