Cleared Traditional

HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS

K060352 · Health Line International Corporation · General Hospital
May 2006
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K060352 is an FDA 510(k) clearance for the HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Health Line International Corporation (Clearfield, US). The FDA issued a Cleared decision on May 31, 2006, 107 days after receiving the submission on February 13, 2006. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K060352 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 2006
Decision Date May 31, 2006
Days to Decision 107 days
Submission Type Traditional
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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