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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 K010727
FOIA Releasable 510(k) K010727
Device Name FLEXLINE CLAMP
Applicant
Novare Surgical Systems, Inc.
200 Gregory Ln. Suite C-100
Pleasant Hill,  CA  94523 -3389
Applicant Contact DAVID W SCHLERF
Correspondent
Novare Surgical Systems, Inc.
200 Gregory Ln. Suite C-100
Pleasant Hill,  CA  94523 -3389
Correspondent Contact DAVID W SCHLERF
Regulation Number870.4450
Classification Product Code
DXC  
Date Received03/12/2001
Decision Date 08/09/2002
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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