Modified Novy Cornual Cannulation Set

Catheters, Salpingography

Cook Incorporated

The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Modified Novy Cornual Cannulation Set.

Pre-market Notification Details

Device IDK180552
510k NumberK180552
Device Name:Modified Novy Cornual Cannulation Set
ClassificationCatheters, Salpingography
Applicant Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington,  IN  47402
ContactNaomi Funkhouser
CorrespondentNaomi Funkhouser
Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington,  IN  47402
Product CodeMOV  
CFR Regulation Number884.4530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-01
Decision Date2018-07-12
Summary:summary

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