NEEDLE-PRO CARTRIDGE

Needle, Hypodermic, Single Lumen

CONCORD/PORTEX

The following data is part of a premarket notification filed by Concord/portex with the FDA for Needle-pro Cartridge.

Pre-market Notification Details

• Device ID: K923127
• 510k Number: K923127
• Device Name: NEEDLE-PRO CARTRIDGE
• Classification: Needle, Hypodermic, Single Lumen
• Applicant: CONCORD/PORTEX 15 KITT ST. Keene, NH 03431
• Contact: Robert Wheeler
• Correspondent: Robert Wheeler; CONCORD/PORTEX 15 KITT ST. Keene, NH 03431
• Product Code: FMI
• CFR Regulation Number: 880.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-06-26
• Decision Date: 1993-04-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
35019517039621	K923127	000
30351688046820	K923127	000
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