20 MICRON HIGH CAPACITY TRANS/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 20 Micron High Capacity Trans/filter.

Pre-market Notification Details

Device IDK830057
510k NumberK830057
Device Name:20 MICRON HIGH CAPACITY TRANS/FILTER
ClassificationMicrofilter, Blood Transfusion
Applicant TRAVENOL LABORATORIES, S.A. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCAK  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-01-07
Decision Date1983-01-26

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