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510(k) K093312

KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM by Kimberly-Clark Corp. — Product Code KGC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2009
Date Received
October 22, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Tube, Gastro-Enterostomy
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

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  • K112805 — KIMGUARD ONE-STEP STERILIZATION WRAP (June 22, 2012)
  • K113340 — KIMBERLY-CLARK CHILD'S FACEMASK (May 4, 2012)
  • K113423 — KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE (March 9, 2012)
  • K112300 — KIMGUARD SMART-FOLD* STERILIZATION WRAP (January 19, 2012)

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