Cleared Traditional

NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EO

K092908 · Neomed, Inc. · General Hospital
Mar 2010
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K092908 is an FDA 510(k) clearance for the NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EO, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Neomed, Inc. (Swanee, US). The FDA issued a Cleared decision on March 10, 2010, 169 days after receiving the submission on September 22, 2009. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K092908 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2009
Decision Date March 10, 2010
Days to Decision 169 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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