FALCON IVF ONE WELL DISH

Labware, Assisted Reproduction

BECTON DICKINSON LABWARE

The following data is part of a premarket notification filed by Becton Dickinson Labware with the FDA for Falcon Ivf One Well Dish.

Pre-market Notification Details

Device IDK991251
510k NumberK991251
Device Name:FALCON IVF ONE WELL DISH
ClassificationLabware, Assisted Reproduction
Applicant BECTON DICKINSON LABWARE 1 BECTON DR. Franklin Lakes,  NJ  07465 -1886
ContactDavid Ball
CorrespondentDavid Ball
BECTON DICKINSON LABWARE 1 BECTON DR. Franklin Lakes,  NJ  07465 -1886
Product CodeMQK  
CFR Regulation Number884.6160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-04-13
Decision Date1999-05-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50389151000011 K991251 000

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