Saliwell L T D

FDA Filings

This page includes the latest FDA filings for Saliwell 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: 3015282800
• FEI Number: 3015282800
• Name: SALIWELL LTD.
• Owner & Operator: Saliwell Ltd.
• Contact Address: 65 Hatamar St. ; Harutzim IL-M HaMerkaz 60917 IL
• Official Correspondent:
  • Andy Wolff
  • 972-50-8801852-x
• US Agent:
  • FDAImports.com, LLC
  • 410 2202800
  • registration@fdaimports.com
• Importing Logistics Registration:
  • Importer: Alan Guggenheim
  • Address: 678 Meadowbrook Drive ; Huntingdon Valley, PA 19006 UNITED STATES
  • Importer Type: End User
• Importing Logistics Registration:
  • Importer: Alison Siewert
  • Address: 450 E Chestnut St ; Lancaster, PA 17602 UNITED STATES
  • Importer Type: End User
• Importing Logistics Registration:
  • Importer: Allison Chipman
  • Address: 6005 SE 4th Street ; Midwest City, OK 73110 UNITED STATES
  • Importer Type: End User
• Importing Logistics Registration:
  • Importer: Angela Benner
  • Address: 141 New Cut Rd ; Piedmont, SC 29673 UNITED STATES
• Importing Logistics Registration:
  • Importer: Anita Baker
  • Address: 7739 Westerville Rd. ; Clayton, IN 46118 UNITED STATES
  • Importer Type: End User
• Importing Logistics Registration:
  • Importer: April Roselli
  • Address: 11200 Askew Ave. ; Kansas City, MO 64137 UNITED STATES
  • Importer Type: End User
• Importing Logistics Registration:
  • Importer: Barbara Henderson
  • Address: 24190 N MacArthur ; Edmond, OK 73025 UNITED STATES
  • Importer Type: End User
• Importing Logistics Registration:
  • Importer: Barbara Mitchell
  • Address: Box Street 544 ; Noblesville, IN 46061 UNITED STATES
  • Importer Type: End User
• Importing Logistics Registration:
  • Importer: Beverly Barker
  • Address: 1112 Kingston Boulevard ; Edmond, OK 73034 UNITED STATES
  • Importer Type: End User
• Importing Logistics Registration:
  • Importer: Carol Robinson
  • Address: 3612 E 51st street ; Indianapolis, IN 46205 UNITED STATES
  • Importer Type: End User
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 65 Hatamar St. ; Harutzim HaMerkaz, 60917 IL
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K180838 | LTF SALIWELL LTD.	SaliPen	2019-03-05
PMN K180838 Saliwell Ltd.	SaliPen	2018-11-06
PMN K160799 SALIWELL LTD.	GenNarino	2017-02-17