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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 K861119
Device Name WALLANT NEUROLOGIX DUAL PUR NERVE/NEUROMUSCU STIMU
Applicant
Wallant Intl. Trade, Inc.
312 - 314 Cox St.
Roselle,  NJ  07203
Applicant Contact ELMER ARLUCK
Correspondent
Wallant Intl. Trade, Inc.
312 - 314 Cox St.
Roselle,  NJ  07203
Correspondent Contact ELMER ARLUCK
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received03/06/1986
Decision Date 08/14/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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