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FDA 510(k) Application Details - K001043
Device Classification Name
Set, Transfer (Blood/Plasma)
More FDA Info for this Device
510(K) Number
K001043
Device Name
Set, Transfer (Blood/Plasma)
Applicant
KAWASUMI LABORATORIES AMERICA, INC.
5905 C HAMPTON OAKS PKWY.
TAMPA, FL 33610 US
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Contact
JACK PAVLO
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
03/31/2000
Decision Date
05/19/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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