Medisut S A

FDA Filings

This page includes the latest FDA filings for Medisut S 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: 3008483449
• FEI Number: 3008483449
• Name: MEDISUT, S.A.
• Owner & Operator: Medisut, S.A.
• Contact Address: Km 12.5 Carretera Norte Edificio 4A Corporacion de Zona Francas Las Mercedes; Managua NI-MN Managua 10000 NI
• Official Correspondent:
  • Alejandro Salinas
  • 505-8-7682268-x
• US Agent:
  • ALEXANDER S. ORLOFSKY
  • THE ORLOFSKY LAW FIRM P.L.
  • 305 5382344
  • 305 9075248
  • alex@orlofskylawfirm.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Km 12.5 Carretera Norte Edificio 4A Corporacion de Zona Francas Las Mercedes; Managua Managua, 10000 NI
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K072930 | GAL MEDISUT, S.A.	Natural Suture	2016-01-25
PMN K043330 | GAW MEDISUT, S.A.	Polypropylene Suture	2016-01-25
PMN K023030 | GAT MEDISUT, S.A.	Polyethylene Suture	2016-01-25
PMN K023029 | GAP MEDISUT, S.A.	Silk Suture	2016-01-25
PMN K023028 | GAR MEDISUT, S.A.	Polypropylene Suture	2016-01-25