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510(k) K844803

POLYESTER CARDIOTOMY RESERVOIR, FILTERED & UNFILTE by Electromedics, Inc. — Product Code DTP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1985
Date Received
December 11, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Defoamer, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4230
Review Panel
CV
Submission Type

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