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510(k) K153663

Vario 8/18/ci by Medela AG — Product Code BTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2016
Date Received
December 21, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Portable, Aspiration (Manual Or Powered)
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type

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