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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K173955
Device Name Mic-Key* SF Over-the-Wire Stoma Measuring Device
Applicant
Halyard Health, Inc.
5405 Windward Parkway
Alpharetta,  GA  30004
Applicant Contact David M Lee
Correspondent
Halyard Health, Inc.
5405 Windward Parkway
Alpharetta,  GA  30004
Correspondent Contact David M Lee
Regulation Number876.5980
Classification Product Code
KNT  
Date Received12/28/2017
Decision Date 01/26/2018
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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