O M Halyard South Africa

FDA Filings

This page includes the latest FDA filings for O M Halyard South Africa. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3016418411
• FEI Number: 3016418411
• Name: O and M Halyard South Africa
• Owner & Operator: O&M Halyard, Inc.
• Contact Address: 9120 Lockwood Blvd ; Mechanicsville VA 23116 US
• Official Correspondent:
  • Angela Bunn
  • 1-470-4485856-x
• US Agent:
  • Angela Bunn
  • O&M HALYARD, INC.
  • 470 4485856
  • angela.bunn@hyh.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3RD FLOOR 54 MELROSE BOULEVARD; MELROSE ARCH Gauteng, 2196 ZA
• Establishment Type: Export Device to the United States But Perform No Other Operation on Device

FDA Filings

Device Company	Device	Date
PMN K842115 | KKX O and M Halyard South Africa [O&M Halyard, Inc.]	SURGICAL GOWN	2018-05-02
PMN K842115 | KKX O and M Halyard South Africa [O&M Halyard, Inc.]	SURGICAL DRAPE HALYARD	2018-05-02
PMN K842115 | KKX O and M Halyard South Africa [O&M Halyard, Inc.]	GOWN, DRAPE PACKS	2018-05-02
PMN K111402 | FXX O and M Halyard South Africa [O&M Halyard, Inc.]	SURGICAL MASK	2018-05-02
PMN K110455 | FXX O and M Halyard South Africa [O&M Halyard, Inc.]	SURGICAL MASK	2018-05-02
FYF O and M Halyard South Africa [O&M Halyard, Inc.]	SURGICAL CAP	2018-05-02