KENDRO HERACELL CO2 INCUBATOR

Accessory, Assisted Reproduction

KENDRO LABORATORY PRODUCTS, L.P.

The following data is part of a premarket notification filed by Kendro Laboratory Products, L.p. with the FDA for Kendro Heracell Co2 Incubator.

Pre-market Notification Details

Device IDK002805
510k NumberK002805
Device Name:KENDRO HERACELL CO2 INCUBATOR
ClassificationAccessory, Assisted Reproduction
Applicant KENDRO LABORATORY PRODUCTS, L.P. 55 NORTHERN BLVD.; SUITE 200 Great Neck,  NY  11021
ContactSusan D Goldstein-falk
CorrespondentSusan D Goldstein-falk
KENDRO LABORATORY PRODUCTS, L.P. 55 NORTHERN BLVD.; SUITE 200 Great Neck,  NY  11021
Product CodeMQG  
CFR Regulation Number884.6120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-09-08
Decision Date2000-11-09

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