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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 K000098
Device Name SOFTLINE SPRING CLIP
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 Received01/13/2000
Decision Date 04/12/2000
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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