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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 K010694
Device Name INCLUDER CLAMP
Applicant
Novare Surgical Systems, Inc.
10231 Bubb Rd.
Cupertino,  CA  95014
Applicant Contact TERRY BUELNA
Correspondent
Novare Surgical Systems, Inc.
10231 Bubb Rd.
Cupertino,  CA  95014
Correspondent Contact TERRY BUELNA
Regulation Number870.4450
Classification Product Code
DXC  
Date Received03/08/2001
Decision Date 02/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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