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FDA 510(k) Application Details - K172957
Device Classification Name
Set, Transfer (Blood/Plasma)
More FDA Info for this Device
510(K) Number
K172957
Device Name
Set, Transfer (Blood/Plasma)
Applicant
Kawasumi Laboratories, Inc.
Shinagawa Intercity Tower B, 9th Floor
2-15-2, Konan, Minato-Ku
Tokyo 108-6109 JP
Other 510(k) Applications for this Company
Contact
Takayuki Nakajima
Other 510(k) Applications for this Contact
Regulation Number
864.9875
More FDA Info for this Regulation Number
Classification Product Code
KSB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/26/2017
Decision Date
09/28/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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