25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-261

Cells, Animal And Human, Cultured

PROTEINS INTL., INC.

The following data is part of a premarket notification filed by Proteins Intl., Inc. with the FDA for 25 Cm2, 75 Cm2, 150 Cm2 Flask, Catalog #03-261.

Pre-market Notification Details

Device IDK930391
510k NumberK930391
Device Name:25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-261
ClassificationCells, Animal And Human, Cultured
Applicant PROTEINS INTL., INC. 1858 STAR BATT DR. Rochester Hills,  MI  48309
ContactVictoria E Walley
CorrespondentVictoria E Walley
PROTEINS INTL., INC. 1858 STAR BATT DR. Rochester Hills,  MI  48309
Product CodeKIR  
CFR Regulation Number864.2280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-01-26
Decision Date1993-03-24

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