Y Agata Optic Prima Co L T D

FDA Filings

This page includes the latest FDA filings for Y Agata Optic Prima Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 8031584
• FEI Number: 6508
• Name: Swea Nightingale
• Owner & Operator: Y. AGATA, OPTIC PRIMA CO., LTD.
• Contact Address: 8-7, Bunkyo 7-chome --; FUKUI CITY, FUKUI JP-NOTA 9100017 JP
• US Agent:
  • Swea Nightingale
  • The Vision Council
  • 703 5484560
  • 703 5484580
  • fda@thevisioncouncil.org
• Importing Logistics Registration:
  • Importer: Sama Eyewear
  • Address: 8460 Santa Monica Blvd, ; Los Angeles, CA 90069 UNITED STATES
  • Phone: 1 323 8223955
  • FAX: 1 323 8223963
  • Importer Type: Retailer
• Importing Logistics Registration:
  • Importer: ULTRA PALM OPTICAL
  • Address: 20157 NE 16 Place North Miami Beach ; Miami, FL 33179 UNITED STATES
• Importing Logistics Registration:
  • Importer: Voradi New York
  • Address: 1204 Avenue U Suite 1113 ; Brooklyn, NY 11229 UNITED STATES
  • Email Address: info@voradi.com
  • Phone: 1 917 7090647
• Importing Logistics Registration:
  • Importer: Zyloware Corporation
  • Address: 8 Slater Street Port Chester ; Port Chester, NY 10573 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 225 Reinekers Lane, Ste. 700 ; ALEXANDRIA, VA 22314 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
HQY Swea Nightingale [Y. AGATA, OPTIC PRIMA CO., LTD.]	SUNGLASS	1987-10-01
HQY Swea Nightingale [Y. AGATA, OPTIC PRIMA CO., LTD.]	SUNGLASS LENS AND ALL	1987-10-01
HQY Swea Nightingale [Y. AGATA, OPTIC PRIMA CO., LTD.]	NON-PRESCRIPTION	1987-10-01
HQY Swea Nightingale [Y. AGATA, OPTIC PRIMA CO., LTD.]	INCLUDING PHOTOSENSITIVE	1987-10-01