RI Witness Embryology Heated Plate

Accessory, Assisted Reproduction

RESEARCH INSTRUMENTS LIMITED

The following data is part of a premarket notification filed by Research Instruments Limited with the FDA for Ri Witness Embryology Heated Plate.

Pre-market Notification Details

Device IDK160504
510k NumberK160504
Device Name:RI Witness Embryology Heated Plate
ClassificationAccessory, Assisted Reproduction
Applicant RESEARCH INSTRUMENTS LIMITED BICKLAND INDUSTRIAL PARK Falmouth,  GB Tr11 4ta
ContactWendy Hassan
CorrespondentWendy Hassan
RESEARCH INSTRUMENTS LIMITED BICKLAND INDUSTRIAL PARK Falmouth,  GB Tr11 4ta
Product CodeMQG  
CFR Regulation Number884.6120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-24
Decision Date2016-07-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060488041532 K160504 000
05060488041525 K160504 000
05060170185834 K160504 000

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