Cleared Special

LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEAL

K113683 · Hospira, Inc. · General Hospital
Jan 2012
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K113683 is an FDA 510(k) clearance for the LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEAL, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Hospira, Inc. (Lake Forest, US). The FDA issued a Cleared decision on January 12, 2012, 28 days after receiving the submission on December 15, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K113683 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2011
Decision Date January 12, 2012
Days to Decision 28 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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