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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
Original Applicant
KIMBERLY-CLARK CORPORATION
1400 holcomb bridge rd.
bldg 300/1
roswell,  GA  30076
Original Contact david lee
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
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