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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K935395
Device Name NEURON II AND MICROTENS
Applicant
Datran Corp.
319 Peck St.
New Haven,  CT  06513
Applicant Contact JOHN T HANSEN
Correspondent
Datran Corp.
319 Peck St.
New Haven,  CT  06513
Correspondent Contact JOHN T HANSEN
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received11/09/1993
Decision Date 04/15/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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