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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 K040193
Device Name MODEL GST-1
Applicant
MEDICAL EQUIPMENT DEVICE SPECIALISTS
9811 W. CHARLESTON #2387
LAS VEGAS,  NV  89117
Applicant Contact C.A. TEKLINSKI
Correspondent
MEDICAL EQUIPMENT DEVICE SPECIALISTS
9811 W. CHARLESTON #2387
LAS VEGAS,  NV  89117
Correspondent Contact C.A. TEKLINSKI
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Code
IPF  
Date Received01/28/2004
Decision Date 04/27/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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