NEOCARE 20 MICRON BLOOD FILTER

Microfilter, Blood Transfusion

WHATMAN, INC.

The following data is part of a premarket notification filed by Whatman, Inc. with the FDA for Neocare 20 Micron Blood Filter.

Pre-market Notification Details

Device IDK000719
510k NumberK000719
Device Name:NEOCARE 20 MICRON BLOOD FILTER
ClassificationMicrofilter, Blood Transfusion
Applicant WHATMAN, INC. 401 WEST MORGAN RD. Ann Arbor,  MI  48108 -9109
ContactRandall D Bath
CorrespondentRandall D Bath
WHATMAN, INC. 401 WEST MORGAN RD. Ann Arbor,  MI  48108 -9109
Product CodeCAK  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-03-03
Decision Date2000-05-30

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