SYREX PRE-FILLED SYRINGE— 510(k) K023740

Clearance details

Applicant

Excelsior Medical Corp.

Product code

Code NZW

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

2002-11-07

Decision date

2003-05-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Neptune, NJ, US

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• Z-1989-2016 — Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV catheters and IV tubing only.Class II·Terminated·Excelsior Medical Corp·20160428

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K023740.