I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411

Set, Administration, Intravascular

CODAN US CORP.

The following data is part of a premarket notification filed by Codan Us Corp. with the FDA for I.v. Set-luer Lock With Latex Free Injection Site, Model B411.

Pre-market Notification Details

• Device ID: K001872
• 510k Number: K001872
• Device Name: I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411
• Classification: Set, Administration, Intravascular
• Applicant: CODAN US CORP. 15412 VERDUN CIRCLE Irvine, CA 92604
• Contact: Richard A Basler
• Correspondent: Richard A Basler; CODAN US CORP. 15412 VERDUN CIRCLE Irvine, CA 92604
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-06-20
• Decision Date: 2000-09-07

NIH GUDID Devices

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