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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electromyograph, diagnostic
510(k) Number K000220
Device Name MA-300 ELECTROMYOGRAPHY SYSTEM
Applicant
MOTION LAB SYSTEMS, INC.
4326 PINE PARK DR.
BATON ROUGE,  LA  70809 -2397
Applicant Contact EDMUND CRAMP
Correspondent
MOTION LAB SYSTEMS, INC.
4326 PINE PARK DR.
BATON ROUGE,  LA  70809 -2397
Correspondent Contact EDMUND CRAMP
Regulation Number890.1375
Classification Product Code
IKN  
Date Received01/24/2000
Decision Date 02/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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