DELTA FLOW

Stopcock, I.v. Set

MEDEX, INC.

The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Delta Flow.

Pre-market Notification Details

• Device ID: K782167
• 510k Number: K782167
• Device Name: DELTA FLOW
• Classification: Stopcock, I.v. Set
• Applicant: MEDEX, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: FMG
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1978-12-29
• Decision Date: 1979-02-21