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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Lesion, Radiofrequency
510(k) Number K101592
Device Name ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM
Applicant
Cheng Medical, Corporation
12945 Saratoga Ave.
Saratoga,  CA  95070
Applicant Contact MARY P GALLUP
Correspondent
Cheng Medical, Corporation
12945 Saratoga Ave.
Saratoga,  CA  95070
Correspondent Contact MARY P GALLUP
Regulation Number882.4400
Classification Product Code
GXD  
Date Received06/07/2010
Decision Date 10/06/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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