WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733

Needle, Assisted Reproduction

SIMS PORTEX LTD.

The following data is part of a premarket notification filed by Sims Portex Ltd. with the FDA for Wallace Oocyte Retrieval Set-16g, Model Meons1633; Wallace Oocyte Retrieval Set-17g, Model Meons1733.

Pre-market Notification Details

Device IDK000628
510k NumberK000628
Device Name:WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733
ClassificationNeedle, Assisted Reproduction
Applicant SIMS PORTEX LTD. HYTHE Kent,  GB Ct21 6jl
ContactGiles Bishop
CorrespondentGiles Bishop
SIMS PORTEX LTD. HYTHE Kent,  GB Ct21 6jl
Product CodeMQE  
CFR Regulation Number884.6100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-24
Decision Date2000-03-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30888937021104 K000628 000
30888937021074 K000628 000
30888937021043 K000628 000

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