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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 K910580
Device Name MICROSTIM 100 MODEL 2C
Applicant
MICROSTIM, INC.
2327 CHESTER DR.
PENNGROVE,  CA  94951
Applicant Contact JOEL ROSSEN
Correspondent
MICROSTIM, INC.
2327 CHESTER DR.
PENNGROVE,  CA  94951
Correspondent Contact JOEL ROSSEN
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received02/11/1991
Decision Date 06/20/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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