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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 ROAD
# 100
KEMAH,  TX  77565
Applicant Contact M. LEE GUNTER
Correspondent
MED-LECTRIC CORPORATION
1909 LAWRENCE ROAD
# 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
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