Cleared Special

PAIN CARE 4200

K020988 · Breg, Inc. · General Hospital
Apr 2002
Decision
8d
Days
Class 2
Risk

About This 510(k) Submission

K020988 is an FDA 510(k) clearance for the PAIN CARE 4200, a Pump, Infusion, Elastomeric (Class II — Special Controls, product code MEB), submitted by Breg, Inc. (Vista, US). The FDA issued a Cleared decision on April 4, 2002, 8 days after receiving the submission on March 27, 2002. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K020988 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 2002
Decision Date April 04, 2002
Days to Decision 8 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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