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510(k) K201916

Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator by Sorin Group Italia S.R.L. — Product Code DTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2020
Date Received
July 10, 2020
Clearance Type
Special
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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