O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set

Catheter, Suprapubic (and Accessories)

Cook Incorporated

The following data is part of a premarket notification filed by Cook Incorporated with the FDA for O'brien Suprapubic Introducer Set, Cook Sp Tube Introducer Set.

Pre-market Notification Details

Device IDK182066
510k NumberK182066
Device Name:O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set
ClassificationCatheter, Suprapubic (and Accessories)
Applicant Cook Incorporated 750 Daniels Way Bloomington,  IN  47404
ContactCarly Powell
CorrespondentCarly Powell
Cook Incorporated 750 Daniels Way Bloomington,  IN  47404
Product CodeKOB  
CFR Regulation Number876.5090 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-01
Decision Date2018-10-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00827002154698 K182066 000

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