NEOSHIELD

Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

JMS North America Corporation

The following data is part of a premarket notification filed by Jms North America Corporation with the FDA for Neoshield.

Pre-market Notification Details

• Device ID: K172499
• 510k Number: K172499
• Device Name: NEOSHIELD
• Classification: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
• Applicant: JMS North America Corporation 22320 Foothill Blvd. Suite 350 Hayward, CA 94541
• Contact: Sho Hosoki
• Correspondent: Yolanda Smith; Smith Assoicates 1468 Harwell Ave Crofton, MD 21114
• Product Code: ONB
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-08-18
• Decision Date: 2018-06-01
• Summary: summary