Ingenjorsfirman Bjorn Bergdahl Ab

FDA Filings

This page includes the latest FDA filings for Ingenjorsfirman Bjorn Bergdahl Ab. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3004605354
• FEI Number: 3004605354
• Name: INGENJORSFIRMAN BJORN BERGDAHL AB
• Owner & Operator: INGENJORSFIRMAN BJORN BERGDAHL AB
• Contact Address: HALLESAS BYVAG 31 --; BILLDAL SE-NOTA SE-427 50 SE
• US Agent:
  • Matthew R Prario
  • Kirwan Surgical Products LLC
  • 781 8349500
  • 781 8340022
  • mprario@ksp.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: HALLESAS BYVAG 31 ; BILLDAL Hallands lan [SE-13], 427 51 SE
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K052203 | GEI INGENJORSFIRMAN BJORN BERGDAHL AB	AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600	2012-11-15
PMN K023733 | GEI INGENJORSFIRMAN BJORN BERGDAHL AB	Coa-Comp/M Automatic Bipolar Coag.	2007-12-04
PMN K023733 INGENJORSFIRMAN BJORN BERGDAHL AB	COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR	2003-05-14