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510(k) K052642

SUTURING WASHER by First Call, Inc. — Product Code MAB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 17, 2006
Date Received: September 26, 2005
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Marker, Cardiopulmonary Bypass (Vein Marker)
Device Class: Class II
Regulation Number: 870.3450
Review Panel: CV
Submission Type