Cleared Traditional

U - STAR (MICRO-STAR)

K860703 · Corning Costar Corp. · General Hospital
May 1986
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K860703 is an FDA 510(k) clearance for the U - STAR (MICRO-STAR), a Set, I.v. Fluid Transfer (Class II — Special Controls, product code LHI), submitted by Corning Costar Corp. (Cambridge, US). The FDA issued a Cleared decision on May 6, 1986, 69 days after receiving the submission on February 26, 1986. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K860703 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 1986
Decision Date May 06, 1986
Days to Decision 69 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code LHI — Set, I.v. Fluid Transfer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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