Cleared Traditional

JMS SYRINGE

K132321 · JMS North America Corporation · General Hospital
Feb 2014
Decision
210d
Days
Class 2
Risk

About This 510(k) Submission

K132321 is an FDA 510(k) clearance for the JMS SYRINGE, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by JMS North America Corporation (Hayward, US). The FDA issued a Cleared decision on February 20, 2014, 210 days after receiving the submission on July 25, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K132321 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2013
Decision Date February 20, 2014
Days to Decision 210 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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