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510(k) K142989

Mini ONE Enteral Extension Set by Applied Medical Technology, Inc. — Product Code PIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2015
Date Received
October 16, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gastrointestinal Tubes With Enteral Specific Connectors
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

To facilitate enteral specific connections.

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