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510(k) K151628

Medline ENFit Connectors by Medline Industries, Inc. — Product Code PIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2015
Date Received
June 17, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enteral Specific Transition Connectors
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Facilitates enteral specific connections between AAMI/CN3(PS):2014 compliant connectors and non ISO 80369-1 compliant legacy enteral connectors.

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