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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name clip, implantable
510(k) Number K020054
Device Name SANARUS INDICA MARKER SYSTEM
Applicant
SANARUS MEDICAL, INC.
5880 WEST LAS POSITAS,SUITE 52
PLEASANTON,  CA  94588
Applicant Contact VINCENT CUTARELLI
Correspondent
SANARUS MEDICAL, INC.
5880 WEST LAS POSITAS,SUITE 52
PLEASANTON,  CA  94588
Correspondent Contact VINCENT CUTARELLI
Regulation Number878.4300
Classification Product Code
FZP  
Subsequent Product Code
GDW  
Date Received01/08/2002
Decision Date 10/16/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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