Halo

Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

J & J Solutions, Inc. D/b/a/Corvida Medical

The following data is part of a premarket notification filed by J & J Solutions, Inc. D/b/a/corvida Medical with the FDA for Halo.

Pre-market Notification Details

• Device ID: K150486
• 510k Number: K150486
• Device Name: Halo
• Classification: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
• Applicant: J & J Solutions, Inc. D/b/a/Corvida Medical 2261 Crosspark Road, Suite 127 Coralville, IA 52241
• Contact: Dana Schramm
• Correspondent: Dana Schramm; J & J Solutions, Inc. D/b/a/Corvida Medical 2261 Crosspark Road, Suite 127 Coralville, IA 52241
• Product Code: ONB
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-02-24
• Decision Date: 2015-07-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20858743005066	K150486	000
20858743005059	K150486	000
20858743005042	K150486	000
20858743005035	K150486	000
20858743005028	K150486	000
20858743005011	K150486	000
20858743005004	K150486	000