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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 K040641
Device Name ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-ACC-1
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 Received03/10/2004
Decision Date 05/05/2004
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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