CODA INCUBATOR CELLMATE

Accessory, Assisted Reproduction

INTL., INC.

The following data is part of a premarket notification filed by Intl., Inc. with the FDA for Coda Incubator Cellmate.

Pre-market Notification Details

Device IDK001600
510k NumberK001600
Device Name:CODA INCUBATOR CELLMATE
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 Received2000-05-24
Decision Date2000-11-22

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