Cleared Traditional

SMALL VOLUME SYRINGE

K062865 · Alcon Laboratories · General Hospital
Aug 2007
Decision
332d
Days
Class 2
Risk

About This 510(k) Submission

K062865 is an FDA 510(k) clearance for the SMALL VOLUME SYRINGE, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Alcon Laboratories (Fort Worth,, US). The FDA issued a Cleared decision on August 23, 2007, 332 days after receiving the submission on September 25, 2006. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K062865 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2006
Decision Date August 23, 2007
Days to Decision 332 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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