BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET

Needle, Hypodermic, Single Lumen

BD

The following data is part of a premarket notification filed by Bd with the FDA for Bd Single Lumen Needle, Syringe And Blood Collection Set.

Pre-market Notification Details

• Device ID: K021475
• 510k Number: K021475
• Device Name: BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET
• Classification: Needle, Hypodermic, Single Lumen
• Applicant: BD 1 BECTON DR. MC 226 Franklin Lakes, NJ 07417
• Contact: Pasquale Amato
• Correspondent: Pasquale Amato; BD 1 BECTON DR. MC 226 Franklin Lakes, NJ 07417
• Product Code: FMI
• Subsequent Product Code: FMF
• Subsequent Product Code: JKA
• CFR Regulation Number: 880.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-05-08
• Decision Date: 2002-07-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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