Cleared Special

ELCAM STOPCOCKS AND MANIFOLDS

K141254 · Elcam Medical Acal · General Hospital
Jul 2014
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K141254 is an FDA 510(k) clearance for the ELCAM STOPCOCKS AND MANIFOLDS, a Stopcock, I.v. Set (Class II — Special Controls, product code FMG), submitted by Elcam Medical Acal (-, IL). The FDA issued a Cleared decision on July 30, 2014, 77 days after receiving the submission on May 14, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K141254 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 2014
Decision Date July 30, 2014
Days to Decision 77 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMG — Stopcock, I.v. Set
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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