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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 K881708
Device Name INDICATENS 4X4
Applicant
ACUDATA SOFTWARE
604 SARTORI DR.
PETALUMA,  CA  94952
Applicant Contact ROSSEN, DVM
Correspondent
ACUDATA SOFTWARE
604 SARTORI DR.
PETALUMA,  CA  94952
Correspondent Contact ROSSEN, DVM
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received04/20/1988
Decision Date 08/11/1988
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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