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510(k) K173834

Quantum Pump Console by Spectrum Medical , Ltd. — Product Code DTQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2018
Date Received
December 18, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4220
Review Panel
CV
Submission Type

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