Cleared Special

PAIN CARE MULTI-PORT CATHETER, MODEL 2000L

K003611 · Breg, Inc. · General Hospital
Dec 2000
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K003611 is an FDA 510(k) clearance for the PAIN CARE MULTI-PORT CATHETER, MODEL 2000L, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Breg, Inc. (Vista, US). The FDA issued a Cleared decision on December 13, 2000, 21 days after receiving the submission on November 22, 2000. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K003611 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2000
Decision Date December 13, 2000
Days to Decision 21 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement

Device Classification

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

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