Cleared Abbreviated

SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800

K023083 · Mettler Electronics Corp. · General Hospital
Feb 2003
Decision
164d
Days
Class 2
Risk

About This 510(k) Submission

K023083 is an FDA 510(k) clearance for the SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Mettler Electronics Corp. (Anaheim, US). The FDA issued a Cleared decision on February 28, 2003, 164 days after receiving the submission on September 17, 2002. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K023083 FDA.gov
FDA Decision Cleared ST
Date Received September 17, 2002
Decision Date February 28, 2003
Days to Decision 164 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FRN — Pump, Infusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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