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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K032589
Device Name ENCLOSE II ANASTOMOSIS ASSIST DEVICE
Applicant
Novare Surgical Systems, Inc.
200 Gregory Ln. Suite C-100
Pleasant Hill,  CA  94523
Applicant Contact DAVID W SCHLERF
Correspondent
Novare Surgical Systems, Inc.
200 Gregory Ln. Suite C-100
Pleasant Hill,  CA  94523
Correspondent Contact DAVID W SCHLERF
Regulation Number870.4450
Classification Product Code
DXC  
Date Received08/22/2003
Decision Date 09/05/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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