RESUBMITTED MICRON TRANSFUSION FILTER

Microfilter, Blood Transfusion

TRAVENOL LABORATORIES, S.A.

The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Resubmitted Micron Transfusion Filter.

Pre-market Notification Details

Device IDK873873
510k NumberK873873
Device Name:RESUBMITTED MICRON TRANSFUSION FILTER
ClassificationMicrofilter, Blood Transfusion
Applicant TRAVENOL LABORATORIES, S.A. WILSON RD. AT ROUTE 120 P.O. BOX 490 Round Lake,  IL  60073
ContactDennis Ocwieja
CorrespondentDennis Ocwieja
TRAVENOL LABORATORIES, S.A. WILSON RD. AT ROUTE 120 P.O. BOX 490 Round Lake,  IL  60073
Product CodeCAK  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-31
Decision Date1987-10-22

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