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510(k) K201642

Paragon Adult Maxi PMP Oxygenator with Tubing Pack by Chalice Medical , Ltd. — Product Code DTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2020
Date Received
June 17, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oxygenator, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4350
Review Panel
CV
Submission Type

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