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510(k) K121161

EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER by Acta Medical, LLC — Product Code KPE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2012
Date Received
April 17, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, I.V.
Device Class
Class II
Regulation Number
880.5025
Review Panel
HO
Submission Type

Other clearances by Acta Medical, LLC

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  • K112863 — ENTERAL ADMINISTRATION SET WITH SOLUTION CONTAINER, ENTERAL ADMINISTRATION SET, (March 29, 2012)

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