BRAIN HEART INFUSION

Culture Media, General Nutrient Broth

HARDY MEDIA

The following data is part of a premarket notification filed by Hardy Media with the FDA for Brain Heart Infusion.

Pre-market Notification Details

Device IDK821597
510k NumberK821597
Device Name:BRAIN HEART INFUSION
ClassificationCulture Media, General Nutrient Broth
Applicant HARDY MEDIA 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJSC  
CFR Regulation Number866.2350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-05-20
Decision Date1982-07-08

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