EMBRYON GIFT TRANSFER CATHETERS/SETS

Catheter, Assisted Reproduction

ROCKET MEDICAL PLC

The following data is part of a premarket notification filed by Rocket Medical Plc with the FDA for Embryon Gift Transfer Catheters/sets.

Pre-market Notification Details

Device IDK000656
510k NumberK000656
Device Name:EMBRYON GIFT TRANSFER CATHETERS/SETS
ClassificationCatheter, Assisted Reproduction
Applicant ROCKET MEDICAL PLC WARE INDUSTRIAL ESTATE Washington, Tyne & Wear,  GB Ne37 1ne
ContactLes Todd
CorrespondentLes Todd
ROCKET MEDICAL PLC WARE INDUSTRIAL ESTATE Washington, Tyne & Wear,  GB Ne37 1ne
Product CodeMQF  
CFR Regulation Number884.6110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-28
Decision Date2000-03-09

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