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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 K013730
Device Name ARIEL RADIO FREQUENCY (RF) ELECTROSURGICAL CONTROL MODULE AND ACCESSORIES
Applicant
Novasys Medical, Inc.
687 # Pastoria Ave.
Sunnyvale,  CA  94086
Applicant Contact THOMAS C WEHMAN
Correspondent
Novasys Medical, Inc.
687 # Pastoria Ave.
Sunnyvale,  CA  94086
Correspondent Contact THOMAS C WEHMAN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/09/2001
Decision Date 02/06/2002
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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