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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 K023435
Device Name MEDS-4 NEUROMUSCULAR STIMULATOR
Applicant
Medical Equipment Device Specialists
32158 Camino Capistrano
Suite A-416
San Juan Capistrano,  CA  92675
Applicant Contact C. A. TEKLINSKI
Correspondent
Medical Equipment Device Specialists
32158 Camino Capistrano
Suite A-416
San Juan Capistrano,  CA  92675
Correspondent Contact C. A. TEKLINSKI
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received10/15/2002
Decision Date 01/13/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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