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510(k) K131272

SIREN EPCR SUITE by Medusa Medical Technologies, Inc. — Product Code DXJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2014
Date Received
May 3, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Display, Cathode-Ray Tube, Medical
Device Class
Class II
Regulation Number
870.2450
Review Panel
CV
Submission Type

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