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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K032584
Device Name RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629
Applicant
Rubicor Medical, Inc.
25 Hartford Ave.
San Carlos,  CA  94070
Applicant Contact ROBERT J CHIN
Correspondent
Rubicor Medical, Inc.
25 Hartford Ave.
San Carlos,  CA  94070
Correspondent Contact ROBERT J CHIN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/21/2003
Decision Date 09/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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