Akita Sumitomo Bakelite Co L T D

FDA Filings

This page includes the latest FDA filings for Akita Sumitomo Bakelite Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3002806337
FEI Number3002806337
NameAkita Sumitomo Bakelite Co., Ltd.
Owner & OperatorSumitomo Bakelite Co., Ltd.
Contact Address5-8, Higashi-Shinagawa 2-Chome
Shinagawa-ku JP-13 Tokyo 140-0002 JP
Official Correspondent
  • Shiro Agehama
  • 81-3-54624811-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address27-4, Aza Nakajimashita, Souzen-machi Tsuchizakiminato
Akita Akita, 011-8510 JP
Establishment Type
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device

FDA Filings

Device
Company
DeviceDate
Akita Sumitomo Bakelite Co., Ltd. [Sumitomo Bakelite Co., Ltd.]
Tentacles NEO2019-10-27
Akita Sumitomo Bakelite Co., Ltd. [Sumitomo Bakelite Co., Ltd.]
SB Knife Jr Type, SB Knife Short Type, SB Knife Standard Type, SB Knife Jr Type - Long2019-06-21
Akita Sumitomo Bakelite Co., Ltd. [Sumitomo Bakelite Co., Ltd.]
Flexible Overtube2019-06-21
Akita Sumitomo Bakelite Co., Ltd. [Sumitomo Bakelite Co., Ltd.]
SB Soft Hood2018-06-01
Akita Sumitomo Bakelite Co., Ltd. [Sumitomo Bakelite Co., Ltd.]
SwiftNINJA Microcatheter2016-11-28

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