510(k) K023083
K023083 is an FDA 510(k) premarket notification submitted by Mettler Electronics Corp. for the device "SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800". The FDA issued a decision of ST on February 28, 2003. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Mettler Electronics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- ST ()
- Decision Date
- February 28, 2003
- Date Received
- September 17, 2002
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type