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510(k) K120587

AMT T-FASTENER ANCHOR KIT by Applied Medical Technology, Inc. — Product Code KGC

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
May 25, 2012
Date Received
February 27, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K073718 — MEDLINE GASTROSTOMY TUBE (March 19, 2008)
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