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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 K895295
Device Name ULTIMA XS MICROCURRENT 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 Received08/25/1989
Decision Date 11/06/1989
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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