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510(k) K172957

Device
Kawasumi Laboratories Blood Drawing Kit (BDK) System
Applicant
Kawasumi Laboratories, Inc.
510(k) number
K172957
Product code
KSB  
Decision
Substantially Equivalent (SESE)
Decision date
2018-09-28
Date received
2017-09-26
Regulation
864.9875
Classification name
Set, Transfer (blood/plasma)
Medical specialty
Hematology
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Takayuki Nakajima
Address
Shinagawa Intercity Tower B, 9th Floor 2-15-2, Konan, Minato-Ku Tokyo JP 108-6109 108-6109

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KSB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K001043KAWASUMI LABORATORY BLOOD DRAWING KITKawasumi Laboratories America, Inc.2000-05-19
K820447ALPHA PLASMA TRANSFER SETAlpha Therapeutic Corp.1982-04-14
K802940SUPER-SPIKE TRANSFER SETGeneva Laboratories, Inc.1981-01-15
K791130FLU-VEN TK-2Venospital, Inc.1979-09-04
K791131FLU VEN TR-1Venospital, Inc.1979-09-04

Legacy Summary#

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FDA Review#

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