GREINER VACUETTE QUICKSHIELD COMPLETE

Needle, Hypodermic, Single Lumen

GREINER BIO-ONE NORTH AMERICA, INC.

The following data is part of a premarket notification filed by Greiner Bio-one North America, Inc. with the FDA for Greiner Vacuette Quickshield Complete.

Pre-market Notification Details

• Device ID: K072320
• 510k Number: K072320
• Device Name: GREINER VACUETTE QUICKSHIELD COMPLETE
• Classification: Needle, Hypodermic, Single Lumen
• Applicant: GREINER BIO-ONE NORTH AMERICA, INC. P.O. BOX 103 Baldwin, MD 21013
• Contact: Judi Smith
• Correspondent: Judi Smith; GREINER BIO-ONE NORTH AMERICA, INC. P.O. BOX 103 Baldwin, MD 21013
• Product Code: FMI
• CFR Regulation Number: 880.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-08-20
• Decision Date: 2007-09-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
39120017577806	K072320	000
29120017577779	K072320	000
39120017577752	K072320	000
39120017577745	K072320	000