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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 K963577
Device Name RADIONICS SLUIJTER-MEHTA CANNULA
Applicant
Radionics, Inc.
22 Terry Ave.
Burlington,  MA  01803
Applicant Contact AMY LAFORTE PH.D.
Correspondent
Radionics, Inc.
22 Terry Ave.
Burlington,  MA  01803
Correspondent Contact AMY LAFORTE PH.D.
Regulation Number882.4400
Classification Product Code
GXD  
Date Received09/06/1996
Decision Date 11/21/1996
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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