Clearance Summary
SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800 received FDA 510(k) clearance under submission number K023083, sponsored by Mettler Electronics Corp.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2003-02-28.
- Submission: K023083
- Applicant / Sponsor: Mettler Electronics Corp.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2003-02-28
Classification & Regulation
This clearance is catalogued under FDA product code FRN and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.