Oncore Mexico

FDA Filings

This page includes the latest FDA filings for Oncore Mexico. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3010152118
• FEI Number: 3010152118
• Name: ONCORE - MEXICO
• Owner & Operator: ONCORE - MEXICO
• Contact Address: 237 Via Vera Cruz ; San Marcos CA 92078 US
• Official Correspondent:
  • Boann Garry
  • x-760-7983237-3237
• US Agent:
  • Boann Garry
  • ONCORE MFG LLC DBA NEOTECH
  • 858 4423805
  • boann.garry@neotech.com
• Importing Logistics Registration:
  • Importer: CareFusion
  • Address: 10020 Pacific Mesa Blvd ; San Diego, CA 92121 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Blvd. Hector Teran Teran #20120 Nave 7-B Parque Industrial Prologis; Tijuana Baja California, 22444 MX
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Export Device to the United States But Perform No Other Operation on Device

FDA Filings

Device Company	Device	Date
PMN K183206 | QBJ ONCORE - MEXICO	Dexcom G6 Continuous Glucose Monitoring System	2019-05-20