Cleared Special

0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE

K011982 · Bd · General Hospital
Jul 2001
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K011982 is an FDA 510(k) clearance for the 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Bd (Franklin Lakes, US). The FDA issued a Cleared decision on July 17, 2001, 21 days after receiving the submission on June 26, 2001. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K011982 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 2001
Decision Date July 17, 2001
Days to Decision 21 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5200

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