QUICK FILL

Injector And Syringe, Angiographic

MEDRAD, INC.

The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Quick Fill.

Pre-market Notification Details

• Device ID: K800823
• 510k Number: K800823
• Device Name: QUICK FILL
• Classification: Injector And Syringe, Angiographic
• Applicant: MEDRAD, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: DXT
• CFR Regulation Number: 870.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1980-04-14
• Decision Date: 1980-04-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10616258007837	K800823	000
10616258005802	K800823	000
40616258022008	K800823	000
40616258024477	K800823	000