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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name staple, implantable
510(k) Number K000060
Device Name GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007
Applicant
SENORX, INC.
13766 ALTON PKWY.
SUITE 144
IRVINE,  CA  92677
Applicant Contact AMY BOUCLY
Correspondent
SENORX, INC.
13766 ALTON PKWY.
SUITE 144
IRVINE,  CA  92677
Correspondent Contact AMY BOUCLY
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
FZP  
Date Received01/10/2000
Decision Date 03/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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