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510(k) K193361

ProCell Surgical Sponge-Blood Recovery Unit by Procell Surgical, Inc. — Product Code CAC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2020
Date Received
December 4, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Autotransfusion
Device Class
Class II
Regulation Number
868.5830
Review Panel
CV
Submission Type

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