COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)

Instrument, Manual, Specialized Obstetric-gynecologic

COOK UROLOGICAL, INC.

The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Cook Word Bartholin Gland Catheter (final Trade Name Not Yet Determined).

Pre-market Notification Details

Device IDK102141
510k NumberK102141
Device Name:COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)
ClassificationInstrument, Manual, Specialized Obstetric-gynecologic
Applicant COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. Spencer,  IN  47460
ContactCindy Foote
CorrespondentCindy Foote
COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. Spencer,  IN  47460
Product CodeKNA  
CFR Regulation Number884.4530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-07-29
Decision Date2011-05-06
Summary:summary

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