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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 K033205
Device Name MANOA BREAST BIOPSY SYSTEM
Applicant
Manoa Medical, Inc.
1017 El Camino
# 361
Redwood City,  CA  94063
Applicant Contact ROBERTA LEE
Correspondent
Manoa Medical, Inc.
1017 El Camino
# 361
Redwood City,  CA  94063
Correspondent Contact ROBERTA LEE
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/02/2003
Decision Date 02/18/2004
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
Predetermined Change
Control Plan Authorized		 No
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