NeoConnect Oral/Enteral Syringes With ENFit Connector (12 ML To 100 ML) And NeoConnect Low Dose Tip Oral/Enteral Syringes With ENFit Connector (0.5 ML To 6mL)

Enteral Syringes With Enteral Specific Connectors

NeoMed, Inc.

The following data is part of a premarket notification filed by Neomed, Inc. with the FDA for Neoconnect Oral/enteral Syringes With Enfit Connector (12 Ml To 100 Ml) And Neoconnect Low Dose Tip Oral/enteral Syringes With Enfit Connector (0.5 Ml To 6ml).

Pre-market Notification Details

• Device ID: K161039
• 510k Number: K161039
• Device Name: NeoConnect Oral/Enteral Syringes With ENFit Connector (12 ML To 100 ML) And NeoConnect Low Dose Tip Oral/Enteral Syringes With ENFit Connector (0.5 ML To 6mL)
• Classification: Enteral Syringes With Enteral Specific Connectors
• Applicant: NeoMed, Inc. 100 Londonderry Ct, Suite 112 Woodstock, GA 30188
• Contact: Tony Lair
• Correspondent: Melinda Harrison Smith; NeoMed, Inc. 100 Londonderry Ct, Suite 112 Woodstock, GA 30188
• 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

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10350770001040	K161039	000
10350770001170	K161039	000
10350770001187	K161039	000
10350770001194	K161039	000
10350770001200	K161039	000
10350770001217	K161039	000
10350770001224	K161039	000
10350770001231	K161039	000
10350770001248	K161039	000
10350770001255	K161039	000
10350770001262	K161039	000
10350770001163	K161039	000
10350770001156	K161039	000
10350770001057	K161039	000
10350770001064	K161039	000
10350770001071	K161039	000
10350770001088	K161039	000
10350770001095	K161039	000
10350770001101	K161039	000
10350770001118	K161039	000
10350770001125	K161039	000
10350770001132	K161039	000
10350770001149	K161039	000
10350770001279	K161039	000
10350770001286	K161039	000
10350770001415	K161039	000
10350770001576	K161039	000
10350770001583	K161039	000
10350770001590	K161039	000
10350770001606	K161039	000
10350770001613	K161039	000
10350770001620	K161039	000
10350770001637	K161039	000
10350770001644	K161039	000
10350770001651	K161039	000
10350770001408	K161039	000
10350770001392	K161039	000
10350770001293	K161039	000
10350770001309	K161039	000
10350770001316	K161039	000
10350770001323	K161039	000
10350770001330	K161039	000
10350770001347	K161039	000
10350770001354	K161039	000
10350770001361	K161039	000
10350770001378	K161039	000
10350770001385	K161039	000
10350770001668	K161039	000