Sumitomo Bakelite Co L T D

FDA Filings

This page includes the latest FDA filings for 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

Registration Number3010141954
FEI Number3010141954
NameTakahito Ishikawa
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 Address900 Lafayette Street, Suite 510,
Santa Clara, CA 95050 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
SUMITOMO BAKELITE COMPANY LIMITED
 Tentacles NEO 2021-04-12
SUMITOMO BAKELITE COMPANY LIMITED
 Tentacle 2020-06-03
SUMITOMO BAKELITE COMPANY LIMITED
 Tentacles NEO 2019-11-25
SUMITOMO BAKELITE COMPANY LIMITED
 SB Knife™ MD-477062019-11-04
SUMITOMO BAKELITE COMPANY LIMITED
 SB Knife™ MD-477042019-11-04
SUMITOMO BAKELITE COMPANY LIMITED
 SB Knife™ MD-47703L2019-11-04
SUMITOMO BAKELITE COMPANY LIMITED
 SB Knife™ MD-47703W2019-11-04
Takahito Ishikawa [Sumitomo Bakelite Co., Ltd.]
Tentacles NEO2019-10-27
Akita Sumitomo Bakelite Co., Ltd. [Sumitomo Bakelite Co., Ltd.]
Tentacles NEO2019-10-27
SUMITOMO BAKELITE COMPANY LIMITED
 Flexible Overtube 2019-10-01
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
Takahito Ishikawa [Sumitomo Bakelite Co., Ltd.]
Flexible Overtube2019-06-21
Akita Sumitomo Bakelite Co., Ltd. [Sumitomo Bakelite Co., Ltd.]
Flexible Overtube2019-06-21
Sumitomo Bakelite Co., Ltd
Flexible Overtube2019-05-15
Sumitomo Bakelite Co., Ltd
SB Knife/Short Type, SB Knife/Standard Type, SB Knife/Jr Type, SB Knife/Jr Type - Long2019-04-23
SUMITOMO BAKELITE COMPANY LIMITED
 SB Soft Hood™ MD-479712018-10-31
SUMITOMO BAKELITE COMPANY LIMITED
 SB Soft Hood™ MD-479702018-10-31
SUMITOMO BAKELITE COMPANY LIMITED
 SB Soft Hood™ MD-479612018-10-31
SUMITOMO BAKELITE COMPANY LIMITED
 SB Soft Hood™ MD-479602018-10-31
SUMITOMO BAKELITE COMPANY LIMITED
 SB Soft Hood™ MD-479512018-10-31
SUMITOMO BAKELITE COMPANY LIMITED
 SB Soft Hood™ MD-479502018-10-31
Takahito Ishikawa [Sumitomo Bakelite Co., Ltd.]
SB Soft Hood2018-06-01
Akita Sumitomo Bakelite Co., Ltd. [Sumitomo Bakelite Co., Ltd.]
SB Soft Hood2018-06-01
Sumitomo Bakelite Co., Ltd
SB Soft Hood - Straight Type, SB Soft Hood - Undercut Type2018-05-08
Akita Sumitomo Bakelite Co., Ltd. [Sumitomo Bakelite Co., Ltd.]
SwiftNINJA Microcatheter2016-11-28
SUMITOMO BAKELITE CO., LTD.
SB Knife Jr Type, SB Knife Short Type, SB Knife Standard Type, SB Knife Jr Type - Long2016-06-17

Related Finance Registrations
NCAGE CodeS4105SUMITOMO BAKELITE CO. LTD
CAGE CodeS4105SUMITOMO BAKELITE CO. LTD
CAGE CodeZ2455SUMITOMO BAKELITE CO LTD
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020080732566Pusan,South Korea -> Long Beach, CaliforniaEPOXY MOLDING COMPOUND55 CTN
2020072952207Pusan,South Korea -> Long Beach, CaliforniaEPOXY MOLDING COMPOUND55 CTN
2020071511536Pusan,South Korea -> Tacoma, WashingtonEPOXY MOLDING COMPOUND800 BAG
2020070124513Pusan,South Korea -> Long Beach, CaliforniaEPOXY MOLDING COMPOUND130 CTN
2020061036257Pusan,South Korea -> Long Beach, CaliforniaEPOXY MOLDING COMPOUND75 CTN
2020051115590Pusan,South Korea -> Tacoma, WashingtonEPOXY MOLDING COMPOUND800 BAG
202004108592Pusan,South Korea -> Tacoma, WashingtonEPOXY MOLDING COMPOUND800 BAG
2020032729404Pusan,South Korea -> Long Beach, CaliforniaEPOXY MOLDING COMPOUND159 CTN
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