AMSure® Enteral Feeding Syringe With ENFit Tip

Enteral Syringes With Enteral Specific Connectors

Amsino International, Inc.

The following data is part of a premarket notification filed by Amsino International, Inc. with the FDA for Amsure® Enteral Feeding Syringe With Enfit Tip.

Pre-market Notification Details

• Device ID: K171857
• 510k Number: K171857
• Device Name: AMSure® Enteral Feeding Syringe With ENFit Tip
• Classification: Enteral Syringes With Enteral Specific Connectors
• Applicant: Amsino International, Inc. 708 Corporate Center Drive Pomona, CA 91768
• Contact: Cathy Hong
• Correspondent: Cathy Hong; Amsino International, Inc. 708 Corporate Center Drive Pomona, CA 91768
• Product Code: PNR
• CFR Regulation Number: 876.5980 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-06-21
• Decision Date: 2018-03-30
• Summary: summary