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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 K963507
Device Name EXTRA TENS (RI-2500) NEO TENS (RI-2000E)
Applicant
COMTEK INTL., CORP.
2 GAMAY CT.
COMMACK,  NY  11725
Applicant Contact PING TSUNG HUAN
Correspondent
COMTEK INTL., CORP.
2 GAMAY CT.
COMMACK,  NY  11725
Correspondent Contact PING TSUNG HUAN
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received09/03/1996
Decision Date 03/19/1997
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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