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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, battery-powered
510(k) Number K822138
Device Name NEUROSTIM II
Applicant
NEURO TECHNOLOGY
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
NEURO TECHNOLOGY
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.2775
Classification Product Code
BXN  
Date Received07/19/1982
Decision Date 07/30/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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