DEMAND C02

Enzymatic, Carbon-dioxide

COOPER BIOMEDICAL, INC.

The following data is part of a premarket notification filed by Cooper Biomedical, Inc. with the FDA for Demand C02.

Pre-market Notification Details

Device IDK841726
510k NumberK841726
Device Name:DEMAND C02
ClassificationEnzymatic, Carbon-dioxide
Applicant COOPER BIOMEDICAL, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKHS  
CFR Regulation Number862.1160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-04-25
Decision Date1984-06-07

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