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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, Microwave And Accessories
510(k) Number K013946
Device Name FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM
Applicant
Afx, Inc.
47929 Fremont Blvd.
Fremont,  CA  94538
Applicant Contact NANCY NORRIS
Correspondent
Afx, Inc.
47929 Fremont Blvd.
Fremont,  CA  94538
Correspondent Contact NANCY NORRIS
Regulation Number878.4400
Classification Product Code
NEY  
Subsequent Product Code
OCL  
Date Received11/29/2001
Decision Date 02/27/2002
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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