Cleared Special

PAIN CARE 3200

K013928 · Breg, Inc. · General Hospital
Dec 2001
Decision
5d
Days
Class 2
Risk

About This 510(k) Submission

K013928 is an FDA 510(k) clearance for the PAIN CARE 3200, a Pump, Infusion, Elastomeric (Class II — Special Controls, product code MEB), submitted by Breg, Inc. (Vista, US). The FDA issued a Cleared decision on December 3, 2001, 5 days after receiving the submission on November 28, 2001. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K013928 FDA.gov
FDA Decision Cleared SESE
Date Received November 28, 2001
Decision Date December 03, 2001
Days to Decision 5 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement

Device Classification

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

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