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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 K844213
Device Name STIMTECH SD PATIENT 6089 #78-8050
Applicant
Codman & Shurtleff, Inc.
41 Pacella Park Dr.
Randolph Industrial Park
Randolph,  MA  02368
Applicant Contact DONALD A LINCOLN
Correspondent
Codman & Shurtleff, Inc.
41 Pacella Park Dr.
Randolph Industrial Park
Randolph,  MA  02368
Correspondent Contact DONALD A LINCOLN
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received10/31/1984
Decision Date 01/10/1985
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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