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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
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