MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT

Microfilter, Blood Transfusion

ASAHI MEDICAL CO., LTD.

The following data is part of a premarket notification filed by Asahi Medical Co., Ltd. with the FDA for Modified Sepacell Pl-series Leukocyte Removal Filt.

Pre-market Notification Details

Device IDK896664
510k NumberK896664
Device Name:MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT
ClassificationMicrofilter, Blood Transfusion
Applicant ASAHI MEDICAL CO., LTD. INTL. SQUARE 1825 EYE ST., N.W., SUITE 400 Washington,  DC  20006
ContactAnderson
CorrespondentAnderson
ASAHI MEDICAL CO., LTD. INTL. SQUARE 1825 EYE ST., N.W., SUITE 400 Washington,  DC  20006
Product CodeCAK  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-11-24
Decision Date1990-01-24

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