Cleared Traditional

3.0 ML RESERVOIR, MODEL 103/193

K991936 · Medtronic Minimed · General Hospital
Jan 2000
Decision
223d
Days
Class 2
Risk

About This 510(k) Submission

K991936 is an FDA 510(k) clearance for the 3.0 ML RESERVOIR, MODEL 103/193, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Medtronic Minimed (Sylmar, US). The FDA issued a Cleared decision on January 18, 2000, 223 days after receiving the submission on June 9, 1999. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K991936 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 1999
Decision Date January 18, 2000
Days to Decision 223 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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

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