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510(k) K231414

CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) by Chalice Medical , Ltd. — Product Code DTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2023
Date Received
May 16, 2023
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

Other clearances by Chalice Medical , Ltd.

  • K201642 — Paragon Adult Maxi PMP Oxygenator with Tubing Pack (September 18, 2020)
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