Zale Atley

FDA Filings

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

Zale Atley holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• ZALE ATLEY

FDA Registration(s)

• Registration Number: 2000010846
• FEI Number: 2000010846
• Name: ZALE ATLEY
• Owner & Operator: MEDICORE CO. LTD.
• Contact Address: 3F, Samwoo B/D, 339-2, Jamsil-dong, Songpa-gu, Seoul, KOREA; Seoul KR-11 Seoul Teugbyeolsi 138867 KR
• Official Correspondent:
  • Byung-kuk YOO
  • 82-2-2056-2650
• US Agent:
  • ZALE ATLEY
  • 512 3960138
  • BKYOO@MEDI-CORE.COM
• Importing Logistics Registration:
  • Importer: Assist Medical
  • Address: 67 35TH STREET 2ND FLOOR ; Brooklyn, NY 11232 UNITED STATES
• Importing Logistics Registration:
  • Importer: Copley Global Services LLC
  • Address: 303 Wyman St Ste 300 ; Waltham, MA 02451 UNITED STATES
  • Phone: 1 617 9665306
• Importing Logistics Registration:
  • Importer: NZ MEDICO GROUP INC.
  • Address: Suite C209 Suite C-209 ; Parsippany, NJ 07054 UNITED STATES
• Importing Logistics Registration:
  • Importer: Shop Anatomical, Inc.
  • Address: 305A Miami,St, ; West Columbia, SC 29170 UNITED STATES
• Importing Logistics Registration:
  • Importer: Sleep Center
  • Address: 2792 OCEAN AVE. UNIT 5, FLOOR 5 ; Brooklyn, NY 11229 UNITED STATES
• Importing Logistics Registration:
  • Importer: the cardio group
  • Address: 5255 W. 11000 N. Suite 225 ; Am Fork, UT 84003 UNITED STATES
• Importing Logistics Registration:
  • Importer: Zale Atley
  • Address: 411 RANCHO ENCINO DR. SAN MARCOS ; San Marcos, TX 78666 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 411 RANCHO ENCINO DR. ; San Marcos, TX 78666 US
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
PMN K110374 | JOM ZALE ATLEY [MEDICORE CO. LTD.]	VasoScan	2012-02-02
PMN K110374 | JOM ZALE ATLEY [MEDICORE CO. LTD.]	Polestar 5000	2012-02-02
PMN K110374 | JOM ZALE ATLEY [MEDICORE CO. LTD.]	Neuro Pulse	2012-02-02
PMN K110374 | JOM ZALE ATLEY [MEDICORE CO. LTD.]	Max Pulse	2012-02-02
PMN K110374 | JOM ZALE ATLEY [MEDICORE CO. LTD.]	CardioWA	2012-02-02
PMN K073323 | JOM ZALE ATLEY [MEDICORE CO. LTD.]	SA-3000P	2008-03-26