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510(k) K043027

MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20 by Applied Medical Technology, Inc. — Product Code KNT

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
December 2, 2004
Date Received
November 3, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

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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