MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES,

Microtools, Assisted Reproduction (pipettes)

COOK UROLOGICAL, INC.

The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Modification To Intracytoplasmic Sperm Injection (isci), Micro-injection Pipettes, Holding Pipettes, Denuding Pipettes,.

Pre-market Notification Details

Device IDK033903
510k NumberK033903
Device Name:MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES,
ClassificationMicrotools, Assisted Reproduction (pipettes)
Applicant COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. Spencer,  IN  47460
ContactBrenda Davis
CorrespondentBrenda Davis
COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. Spencer,  IN  47460
Product CodeMQH  
CFR Regulation Number884.6130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-12-17
Decision Date2004-01-16
Summary:summary

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