UNIFINE

Syringe, Piston

Owen Mumford USA, Inc.

The following data is part of a premarket notification filed by Owen Mumford Usa, Inc. with the FDA for Unifine.

Pre-market Notification Details

• Device ID: K983994
• 510k Number: K983994
• Device Name: UNIFINE
• Classification: Syringe, Piston
• Applicant: Owen Mumford USA, Inc. 849 PICKENS INDUSTRIAL DR. SUITE 14 Marietta, GA 30062
• Contact: Robert Shaw
• Correspondent: Robert Shaw; Owen Mumford USA, Inc. 849 PICKENS INDUSTRIAL DR. SUITE 14 Marietta, GA 30062
• Product Code: FMF
• CFR Regulation Number: 880.5860 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-11-09
• Decision Date: 1999-01-08
• Summary: summary