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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Manual, Specialized Obstetric-Gynecologic
510(k) Number K102141
Device Name COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)
Applicant
Cook Urological, Inc.
1100 W. Morgan St.
Spencer,  IN  47460
Applicant Contact CINDY FOOTE
Correspondent
Cook Urological, Inc.
1100 W. Morgan St.
Spencer,  IN  47460
Correspondent Contact CINDY FOOTE
Regulation Number884.4530
Classification Product Code
KNA  
Date Received07/29/2010
Decision Date 05/06/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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