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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 K043114
Device Name KIMBERLY-CLARK MIC-KEY LOW PROFILE GASTROSTOMY TUBE
Applicant
KIMBERLY-CLARK CORP.
12050 LONE PEAK PARKWAY
DRAPER,  UT  84020
Applicant Contact S. MCMILLAN
Correspondent
KIMBERLY-CLARK CORP.
12050 LONE PEAK PARKWAY
DRAPER,  UT  84020
Correspondent Contact S. MCMILLAN
Regulation Number876.5980
Classification Product Code
KNT  
Date Received11/10/2004
Decision Date 12/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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