GENX CODA AIR PURIFICATION SYSTEM

Accessory, Assisted Reproduction

INTL., INC.

The following data is part of a premarket notification filed by Intl., Inc. with the FDA for Genx Coda Air Purification System.

Pre-market Notification Details

Device IDK001486
510k NumberK001486
Device Name:GENX CODA AIR PURIFICATION SYSTEM
ClassificationAccessory, Assisted Reproduction
Applicant INTL., INC. 170 FORT PATH RD. UNIT 14 Madison,  CT  06443
ContactMichael D Cecchi
CorrespondentMichael D Cecchi
INTL., INC. 170 FORT PATH RD. UNIT 14 Madison,  CT  06443
Product CodeMQG  
CFR Regulation Number884.6120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-05-12
Decision Date2000-09-15

NIH GUDID Devices

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