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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 K071878
Device Name DELTA SCANNER, DELTA SCANNER PRO, DS SPINE PRO, DS SPORTS PRO AND DS REHAB
Applicant
Med-Lectric Corporation
1909 Lawrence Rd.
# 100
Kemah,  TX  77565
Applicant Contact M. LEE GUNTER
Correspondent
Med-Lectric Corporation
1909 Lawrence Rd.
# 100
Kemah,  TX  77565
Correspondent Contact M. LEE GUNTER
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received07/06/2007
Decision Date 12/07/2007
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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