Clearance Summary
FLASHPAK STERILIZATION CONTAINER SYSTEM received FDA 510(k) clearance under submission number K141826, sponsored by Symmetry Medical Inc- Manchester. 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 2015-04-02.
- Submission: K141826
- Applicant / Sponsor: Symmetry Medical Inc- Manchester
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6850
- Decision date: 2015-04-02
Classification & Regulation
This clearance is catalogued under FDA product code FRG and 21 CFR 880.6850, within the General Hospital review panel as a Class II device.