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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 K881424
Device Name PREMIER 10S (TENS)
Applicant
AMERICAN IMEX
16520 ASTON ST.
IRVINE,  CA  92606
Applicant Contact JOAN FONG
Correspondent
AMERICAN IMEX
16520 ASTON ST.
IRVINE,  CA  92606
Correspondent Contact JOAN FONG
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received04/05/1988
Decision Date 04/11/1988
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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