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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K023446
Device Name MEDS-3 NEUROMUSCULAR STIMULATOR
Applicant
Medical Equipment Device Specialists
32158 Camino Capistrano
Suite A-416
San Juan Capistrano,  CA  92675
Applicant Contact DARREL BLOMBERG
Correspondent
Medical Equipment Device Specialists
32158 Camino Capistrano
Suite A-416
San Juan Capistrano,  CA  92675
Correspondent Contact DARREL BLOMBERG
Regulation Number890.5850
Classification Product Code
IPF  
Date Received10/15/2002
Decision Date 01/13/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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