Cleared Traditional

PAIN CONTROL INFUSION PUMP

K990101 · Sgarlato Laboratories, Inc. · General Hospital
Mar 1999
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K990101 is an FDA 510(k) clearance for the PAIN CONTROL INFUSION PUMP, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Sgarlato Laboratories, Inc. (Los Gatos, US). The FDA issued a Cleared decision on March 19, 1999, 66 days after receiving the submission on January 12, 1999. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K990101 FDA.gov
FDA Decision Cleared SESE
Date Received January 12, 1999
Decision Date March 19, 1999
Days to Decision 66 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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