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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 K965182
Device Name RFG-3CF
Applicant
Radionics, Inc.
22 Terry Ave.
Burlington,  MA  01803 -2516
Applicant Contact AMY J LAFORTE
Correspondent
Radionics, Inc.
22 Terry Ave.
Burlington,  MA  01803 -2516
Correspondent Contact AMY J LAFORTE
Regulation Number882.4400
Classification Product Code
GXD  
Date Received12/24/1996
Decision Date 03/12/1997
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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