BIOTROL BICARBONATE (CO2) UV HP)

Enzymatic, Carbon-dioxide

BIOTROL, USA, INC.

The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Biotrol Bicarbonate (co2) Uv Hp).

Pre-market Notification Details

Device IDK874941
510k NumberK874941
Device Name:BIOTROL BICARBONATE (CO2) UV HP)
ClassificationEnzymatic, Carbon-dioxide
Applicant BIOTROL, USA, INC. 5 GREAT VALLEY PKWY, SUITE 248 GREAT VALLEY CORP. CENTER Malvern,  PA  19355
ContactAllan C Murphy
CorrespondentAllan C Murphy
BIOTROL, USA, INC. 5 GREAT VALLEY PKWY, SUITE 248 GREAT VALLEY CORP. CENTER Malvern,  PA  19355
Product CodeKHS  
CFR Regulation Number862.1160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-12-02
Decision Date1988-01-05

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