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510(k) K113132

DISPOSABLE HEMOSTATIC Y-CONNECTORS by Coeur, Inc. — Product Code DTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2012
Date Received
October 24, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4290
Review Panel
CV
Submission Type

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Other clearances for product code DTL

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  • K113148 — E-PASS (February 28, 2012)
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