Randy Burhans

FDA Filings

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

FDA Registration(s)
Registration Number3008998088
FEI Number3008998088
NameRandy Burhans
Owner & OperatorYuwa Seisakusho KK
Contact Address2136 Michishita, Kayama
Odawara JP-14 Kanagawa 250-0852 JP
Official Correspondent
  • Soue Honna
  • 81-465-360607-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3750 Palladian Village Drive, Building 400, Unit 410
Marietta, GA 30066 US
Establishment TypeManufacture Medical Device



Registration Number3003627846
FEI Number3003627846
NameRandy Burhans
Owner & OperatorToyo Polymack Co., Ltd.
Contact Address6F,Supre Okamura Bldg, 20-6, Taito 4-Chome
Taito-Ku JP-13 Tokyo 110-0016 JP
Official Correspondent
  • Mitsuyoshi Kitagawa
  • 81-3-58177066-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3750 Palladian Village Drive Building 400 Unit 410
Marietta, GA 30066 US
Establishment TypeExport Device to the United States But Perform No Other Operation on Device




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