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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 K872398
Device Name T.E.N.S. DEVICE MODEL SPL 2000
Applicant
Spartan Laboratories, Inc.
2450 Chandler. Suite 17
Las Vegas,  NV  89120
Applicant Contact R MALDONADO
Correspondent
Spartan Laboratories, Inc.
2450 Chandler. Suite 17
Las Vegas,  NV  89120
Correspondent Contact R MALDONADO
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received06/22/1987
Decision Date 07/29/1987
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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