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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 K901726
Device Name LUMISCOPE MICRO 100
Applicant
LUMISCOPE CO., INC.
400 RARITAN CENTER PKWY.
EDISON,  NJ  08837
Applicant Contact C MORGENIER
Correspondent
LUMISCOPE CO., INC.
400 RARITAN CENTER PKWY.
EDISON,  NJ  08837
Correspondent Contact C MORGENIER
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received04/16/1990
Decision Date 08/14/1990
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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