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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 K890088
Device Name ACUDATA INDICATENS MODEL 5X
Applicant
ACUDATA SOFTWARE
604 SARTORI DR.
PETALUMA,  CA  94952
Applicant Contact JOEL ROSSEN
Correspondent
ACUDATA SOFTWARE
604 SARTORI DR.
PETALUMA,  CA  94952
Correspondent Contact JOEL ROSSEN
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received01/10/1989
Decision Date 05/26/1989
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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