Monoject

Enteral Syringes With Enteral Specific Connectors

Covidien

The following data is part of a premarket notification filed by Covidien with the FDA for Monoject.

Pre-market Notification Details

• Device ID: K161045
• 510k Number: K161045
• Device Name: Monoject
• Classification: Enteral Syringes With Enteral Specific Connectors
• Applicant: Covidien 15 Hampshire Street Mansfield, MA 02048
• Contact: Sona Manickam
• Correspondent: Sona Manickam; Covidien 15 Hampshire Street Mansfield, MA 02048
• Product Code: PNR
• CFR Regulation Number: 876.5980 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-04-13
• Decision Date: 2016-06-17
• Summary: summary