Elkem Siliconi Italia S P A

FDA Filings

This page includes the latest FDA filings for Elkem Siliconi Italia S P A. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3003913694
• FEI Number: 3003913694
• Name: Elkem SILICONI ITALIA S.p.A
• Owner & Operator: Elkem Silicones USA Corp.
• Contact Address: 7979 Park Place Road ; York SC 29745 US
• US Agent:
  • Karen Ruble
  • Elkem Silicones USA Corp.
  • 803 7923161
  • karen.ruble@elkem.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: VIA ARCHIMEDE 602 ; CARONNO PERTUSELLA Varese, 21042 IT
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K052409 | ELW Elkem SILICONI ITALIA S.p.A [Elkem Silicones USA Corp.]	Silbione RTV	2008-01-16
PMN K043054 | ELW Elkem SILICONI ITALIA S.p.A [Elkem Silicones USA Corp.]	Silbione RTV	2008-01-16
PMN K030414 | ELW Elkem SILICONI ITALIA S.p.A [Elkem Silicones USA Corp.]	Silbione RTV	2008-01-16