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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Marker, Cardiopulmonary Bypass (Vein Marker)
510(k) Number K052642
Device Name SUTURING WASHER
Applicant
First Call, Inc.
P.O. Box 205
Derby,  CT  06418
Applicant Contact DINA L WEISSMAN
Correspondent
First Call, Inc.
P.O. Box 205
Derby,  CT  06418
Correspondent Contact DINA L WEISSMAN
Regulation Number870.3450
Classification Product Code
MAB  
Date Received09/26/2005
Decision Date 01/17/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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