Cleared Traditional

SYRINGE INFUSION PUMP

K860353 · Travenol Laboratories, S.A. · General Hospital
Sep 1986
Decision
218d
Days
Class 2
Risk

About This 510(k) Submission

K860353 is an FDA 510(k) clearance for the SYRINGE INFUSION PUMP, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Travenol Laboratories, S.A. (Hooksett, US). The FDA issued a Cleared decision on September 5, 1986, 218 days after receiving the submission on January 30, 1986. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K860353 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 1986
Decision Date September 05, 1986
Days to Decision 218 days
Submission Type Traditional
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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