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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 K122653
Device Name MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES
Applicant
KIMBERLY-CLARK CORPORATION
1400 HOLCOMB BRIDGE RD.
BLDG 300/1
ROSWELL,  GA  30076
Applicant Contact DAVID LEE
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number876.5980
Classification Product Code
KNT  
Date Received08/31/2012
Decision Date 06/26/2013
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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