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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Ablation, Ultrasound And Accessories
510(k) Number K022894
Device Name EPICOR MEDICAL ABLATION SYSTEM
Applicant
Epicor Medical, Inc.
240 Santa Ana Ct.
Sunnyvale,  CA  94085
Applicant Contact KATHI GUERRANT
Correspondent
Epicor Medical, Inc.
240 Santa Ana Ct.
Sunnyvale,  CA  94085
Correspondent Contact KATHI GUERRANT
Regulation Number878.4400
Classification Product Code
NTB  
Subsequent Product Code
OCL  
Date Received09/03/2002
Decision Date 02/26/2004
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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