Cleared Traditional

BD SPRING BASED SYRINGE

K011103 · Bd · General Hospital
Jun 2001
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K011103 is an FDA 510(k) clearance for the BD SPRING BASED SYRINGE, a Syringe, Antistick (Class II — Special Controls, product code MEG), submitted by Bd (Franklin Lakes, US). The FDA issued a Cleared decision on June 13, 2001, 63 days after receiving the submission on April 11, 2001. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K011103 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2001
Decision Date June 13, 2001
Days to Decision 63 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code MEG — Syringe, Antistick
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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