ALPHA MICRON 20 MICROAGGREGATE FILTER

Microfilter, Blood Transfusion

ALPHA THERAPEUTIC CORP.

The following data is part of a premarket notification filed by Alpha Therapeutic Corp. with the FDA for Alpha Micron 20 Microaggregate Filter.

Pre-market Notification Details

Device IDK955515
510k NumberK955515
Device Name:ALPHA MICRON 20 MICROAGGREGATE FILTER
ClassificationMicrofilter, Blood Transfusion
Applicant ALPHA THERAPEUTIC CORP. 5555 VALLEY BLVD. Los Angeles,  CA  90032
ContactM. Sue Preston
CorrespondentM. Sue Preston
ALPHA THERAPEUTIC CORP. 5555 VALLEY BLVD. Los Angeles,  CA  90032
Product CodeCAK  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-12-04
Decision Date1996-02-12

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