Stephen H Gorski

FDA Filings

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

FDA Registration(s)

• Registration Number: 3007773209
• FEI Number: 3007773209
• Name: STEPHEN H. GORSKI
• Owner & Operator: ENVISEN INC.
• Contact Address: BLOCK A SIMPLE DRAGON INDUSTRIAL PARK; SHENZHEN CN-NOTA 518000 CN
• US Agent:
  • STEPHEN H. GORSKI
  • IMAGENIX, INC.
  • 262 5942114 0
  • 262 5945399
  • stephengorski@me.com
• Importing Logistics Registration:
  • Importer: Healthcare Logistics Systems LLC
  • Address: 4348 NVV 120th Avenue Coral Springs Florida 33065 ; Coral Springs, FL 33065 UNITED STATES
• Importing Logistics Registration:
  • Importer: MAXTEC
  • Address: 2305 SOUTH 1070 WEST SALT LAKE CITY, UT 84119 ; Granger, UT 84119 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: S65 W35739 PIPER ROAD ; Eagle, WI 53119 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
CCX STEPHEN H. GORSKI [ENVISEN INC.]	QView	2018-07-05
OFP STEPHEN H. GORSKI [ENVISEN INC.]	Qtube	2018-04-17
OFP STEPHEN H. GORSKI [ENVISEN INC.]	ExtendaFlow	2018-04-17
OFP STEPHEN H. GORSKI [ENVISEN INC.]	CoreFlow	2018-04-17
PMN K103584 | DQA STEPHEN H. GORSKI [ENVISEN INC.]	Envisen Reusable SPO2 Sensors	2011-12-28
PMN K103584 | DQA STEPHEN H. GORSKI [ENVISEN INC.]	Envisen Disposable and Reusable SPO2 Sensors	2011-12-28
PMN K103584 | DQA STEPHEN H. GORSKI [ENVISEN INC.]	Envisen Disposable SPO2 Sensors	2011-12-28

Similar & Related FDA Registered Companies

• IMAGENIX, INC.