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510(k) K122653

MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES by Kimberly-Clark Corporation — Product Code KNT

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
June 26, 2013
Date Received
August 31, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

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