Cleared Special

SPLIT SEPTUM INJECTION SITES

K041042 · Fresenius Medical Care North America · General Hospital
Jul 2004
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K041042 is an FDA 510(k) clearance for the SPLIT SEPTUM INJECTION SITES, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Fresenius Medical Care North America (Lexington, US). The FDA issued a Cleared decision on July 16, 2004, 85 days after receiving the submission on April 22, 2004. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K041042 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 2004
Decision Date July 16, 2004
Days to Decision 85 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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