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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 K840964
Device Name SD PLUS CLINICIAN CAT# 78-8015
Applicant
Codman & Shurtleff, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Codman & Shurtleff, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received03/06/1984
Decision Date 04/23/1984
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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