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510(k) K190282

Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) by Spectrum Medical , Ltd. — Product Code DTQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2019
Date Received
February 11, 2019
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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