Enteral Syringe With ENFit Connector (10 Ml To 60 Ml), Enteral Syringe With ENFit Low Dose Tip (1 Ml To 5 Ml)

Enteral Syringes With Enteral Specific Connectors

VR MEDICAL TECHNOLOGY

The following data is part of a premarket notification filed by Vr Medical Technology with the FDA for Enteral Syringe With Enfit Connector (10 Ml To 60 Ml), Enteral Syringe With Enfit Low Dose Tip (1 Ml To 5 Ml).

Pre-market Notification Details

• Device ID: K162188
• 510k Number: K162188
• Device Name: Enteral Syringe With ENFit Connector (10 Ml To 60 Ml), Enteral Syringe With ENFit Low Dose Tip (1 Ml To 5 Ml)
• Classification: Enteral Syringes With Enteral Specific Connectors
• Applicant: VR MEDICAL TECHNOLOGY 90 GAOXIN ROAD, ZHOUZHANG Kunshan, CN 215325
• Contact: Lee Pan
• Correspondent: Korina A. Akhondzadeh; KARA & ASSOCIATES 6965 EL CAMINO REAL, SUITE 105-428 Carlsbad, CA 92009
• Product Code: PNR
• CFR Regulation Number: 876.5980 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-08-04
• Decision Date: 2016-09-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30817522011541	K162188	000
30817522010636	K162188	000
30817522010629	K162188	000
30817522010612	K162188	000
30817522013231	K162188	000
30817522012746	K162188	000
30817522012739	K162188	000
30817522012722	K162188	000
30020451330946	K162188	000
30817522010643	K162188	000
30817522010650	K162188	000
30817522011534	K162188	000
30817522011527	K162188	000
30817522011510	K162188	000
30817522011503	K162188	000
30817522011497	K162188	000
30817522011480	K162188	000
30817522011473	K162188	000
30817522011466	K162188	000
30020451330939	K162188	000