510(k) K213522

Device: AMSafe Pre-Filled Normal Saline Flush Syringe
Applicant: Amsino International, Inc.
510(k) number: K213522
Product code: NGT
Decision: Substantially Equivalent (SESE)
Decision date: 2022-03-22
Date received: 2021-11-03
Regulation: 880.5200
Classification name: Saline, Vascular Access Flush
Medical specialty: General Hospital
Review panel: General Hospital
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: Jane Gao
Address: 708 Corporate Center Dr. Pomona CA US 91768 91768

FDA Registration Numbers#

Source Documents#

510(k) summary PDF