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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 K982221
Device Name PREMIER AP
Applicant
AMERICAN IMEX
16520 ASTON ST.
IRVINE,  CA  92606
Applicant Contact JOE FONG
Correspondent
AMERICAN IMEX
16520 ASTON ST.
IRVINE,  CA  92606
Correspondent Contact JOE FONG
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received06/24/1998
Decision Date 09/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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