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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 K001897
Device Name MULTI-STIM, MODEL MS-100
Applicant
Metron Medical Australia, Pty, Ltd.
57 Aster Ave.
Carrum Downs,  AU 3201
Applicant Contact ROB HOPKINS
Correspondent
Metron Medical Australia, Pty, Ltd.
57 Aster Ave.
Carrum Downs,  AU 3201
Correspondent Contact ROB HOPKINS
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Code
LIH  
Date Received06/21/2000
Decision Date 06/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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