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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 K900668
Device Name ACUDATA INDICATENS MODEL 5XS
Applicant
ACUDATA SOFTWARE
MEDICAL PRODUCTS DIVISION
2327 CHESTER DRIVE
PENNGROVE,  CA  94951
Applicant Contact JOEL ROSSEN
Correspondent
ACUDATA SOFTWARE
MEDICAL PRODUCTS DIVISION
2327 CHESTER DRIVE
PENNGROVE,  CA  94951
Correspondent Contact JOEL ROSSEN
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received02/13/1990
Decision Date 06/22/1990
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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